ROCHE PALO ALTO LLC et al v. LUPIN PHARMACEUTICALS, INC. et al
Filing
121
OPINION fld. Signed by Judge Esther Salas on 3/21/12. (sr, )
NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
__________________________________________
:
ROCHE PALO ALTO LLC, GILEAD PALO :
ALTO, INC. and GILEAD SCIENCES, INC.
:
:
Plaintiffs,
:
v.
:
CIVIL ACTION NO. 10-3561(ES)
:
LUPIN PHARMACEUTICALS, INC. and
:
OPINION
LUPIN LTD.,
:
:
Defendants.
:
_________________________________________ :
SALAS, District Judge.
This matter is before the Court by way of an application for claims construction by
Plaintiffs Roche Palo Alto LLC (“Roche”) and Gilead Palo Alto, Inc. and Gilead Sciences, Inc.
(“Gilead”) (collectively “Plaintiffs”) and Defendants Lupin Pharmaceuticals, Inc. and Lupin Ltd.
(collectively “Lupin” or “Defendants”). (Docket Entry Nos. 74, 82, 83, & 84). The parties seek
the Court’s interpretation of the following disputed terms: (1) “pH-dependent binder”; (2) “pHindependent binder”; (3) “binder”, (4) “admixture”; (5) “variant and exercised-induced angina”;
and (6) “fillers.” The Court held a Markman hearing on January 19, 2012, and has considered
the parties’ written and oral arguments. The Court sets forth herein its construction of the
disputed claim terms.
I.
INTRODUCTION
This is a Hatch-Waxman Act patent action in which each of the following patents-in-suit
are directed to sustained release ranolazine medications for the treatment of angina—U.S. Patent
Nos. 6,303,607 (“the ’607 patent”); 6,479,496 (“the ’496 patent”); 6,503,911 (“the ’911 patent”);
1
6,525,057 (“the ’057 patent”); 6,562,826 (“the ’826 patent”); 6,617,328 (“the ’328 patent”);
6,620,814 (“the ’814 patent”); 6,852,724 (“the ’724 patent”); 6,864,258 (“the ’258 patent”);
6,369,062 (“the ’062 patent”) (collectively “the patents-in-suit”). Plaintiffs assert, among other
things, that Lupin has infringed the ’607 patent (Claim 1), the ’496 patent (Claims 1-3 and 5-10),
the ’911 patent (Claims 1-4), the ’057 patent (Claims 1-9), the ’826 patent (Claims 1-6, 8, and
10-22), the ’328 patent (Claims 1-10 and 16-33), the ’814 patent (Claims 1-7, 9, and 11-23), the
’724 patent (Claims 1-2, 5-6, and 12-14), and the ’258 (Claims 1-4, 6-13, 18-24, and 28-30)
patent by filing an Abbreviated New Drug Application (“ANDA”) and seeking to commercially
market Lupin’s ANDA Products prior to the expiration of the patents-in-suit. Lupin argues that
the asserted claims of the patents-in-suit are invalid and/or not infringed.
For purposes of most of the terms in dispute, Claim 1 of the ’607 Patent is illustrative.
A method for treating a human patient suffering from variant or exerciseinduced angina by administering a sustained release pharmaceutical dosage form
including at least 50% by weight ranolazine and an admixture of at least one pHdependent binder and at least one pH-independent binder wherein the
pharmaceutical dosage form is administered in no more than two tablets per dose
to the human patient to maintain ranolazine plasma levels in the human patient of
from about 550 to about 7500 ng base/mL for at least 24 hours wherein the dose is
administered at a frequency selected from the group consisting of once, twice or
three times over 24 hours and wherein the peak to trough plasma ranolazine level
does not exceed 3:1 over a 24 hour period.
See, ’607 Patent, Cl. 1 (emphasis added to terms in dispute).
II.
LEGAL STANDARD
A court’s analysis of a patent infringement claim is two-fold. Tate Access Floors, Inc. v.
Interface Architectural Resources, Inc., 279 F.3d 1357, 1365 (Fed. Cir. 2002). The court must
first define the meaning and scope of the patent claims as a matter of law. Markman v. Westview
Instruments, Inc., 52 F.3d 967, 978 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996). The
2
court then engages in a comparison of the claims as construed to the alleged infringing product
(or method). Tate, 279 F.3d at 1365. At this stage, the Court must only engage in the first step.
Claim construction is a matter of law to be determined solely by the court. Phillips v.
AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005), cert. denied, 546 U.S. 1170 (2006). “It is a
bedrock principle of patent law that the claims of a patent define the invention to which the
patentee is entitled the right to exclude.” Id. (quotations omitted). In construing the terms of a
patent, a court should look first to the language of the claim itself.
Vitronics Corp. v.
Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The terms in the claim “are generally
given their ordinary and customary meaning.”1 Id. at 1582. “[T]he ordinary and customary
meaning of a claim term is 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.” Phillips, 415 F.3d at 1313. A court “must look at the ordinary meaning in the
context of the written description and the prosecution history.” Medrad, Inc. v. MRI Devices
Corp., 401 F.3d 1313, 1319 (Fed. Cir. 2005). The court should turn to “those sources available
to the public that show what a person of skill in the art would have understood disputed claim
language to mean.” Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111,
1116 (Fed. Cir. 2004).
To this end, the court should first examine the intrinsic record—the patent itself,
including the claims, the specification, and the prosecution history. Vitronics, 90 F.3d at 1582
(citing Markman, 52 F.3d at 979). The specification “acts as a dictionary when it expressly
1
There are two situations in which the court must enter a definition different from the ordinary and customary
meaning: (1) where the “patentee has chosen to be his or her own lexicographer by clearly setting forth an explicit
definition for a claim term,” Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 990 (Fed. Cir. 1999)
(citing In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994)), and (2) where “the term or terms chosen by the patentee
so deprive the claim of clarity that there is no means by which the scope of the claim may be ascertained from the
language used.” Id. (citing Eastman Kodak Co. v. Goodyear Tire & Rubber Co., 114 F.3d 1547, 1554 (Fed. Cir.
1997)).
3
defines terms used in the claims or when it defines terms by implication.” Id. Indeed, the
Federal Circuit explains that the specification is “ ‘usually . . . dispositive . . . [and] the single
best guide the meaning of a disputed term.’ ” Phillips, 415 F.3d at 1315 (quoting Vitronics, 90
F.3d at 1582). It is “entirely appropriate for a court, when conducting claim construction, to rely
heavily on the written description for guidance as to the meaning of the claims.” Id. at 1317.
The specification is also an important guide in claims construction as it may contain “an
intentional disclaimer, or disavowal, of claim scope by the inventor.” Id. at 1316.
Additionally, the court should consult the patent’s prosecution history as it “provides
evidence of how the [Patent and Trademark Office, (“PTO”)] and the inventor understood the
patent.” Id. The prosecution history is the complete record of the proceedings before the PTO
and includes the prior art cited by the patentee during examination of the patent. Id. at 1317.
Moreover, the prosecution history “can often inform the meaning of the claim language by
demonstrating how the inventor understood the invention and whether the inventor limited the
invention in the course of prosecution, making the claim scope narrower than it would otherwise
be.”
Id.
Indeed, the Federal Circuit has repeatedly emphasized the need to consult the
prosecution history to “exclude any interpretation that was disclaimed during prosecution.”
Chimie v. PPG Indus., 402 F.3d 1371, 1384 (Fed. Cir. 2005).
A district court may also examine extrinsic evidence—that is “all evidence external to the
patent and prosecution history.” Markman, 52 F.3d at 980; Phillips, 415 F.3d at 1317-18 (stating
that the Federal Circuit “ha[s] authorized district courts to rely on extrinsic evidence”). Such
evidence consists of testimony by the inventor or by experts, dictionaries, and treatises.
Markman, 52 F.3d at 980. In particular, a court may find reference to technical dictionaries
useful “in determining the meaning of particular terminology.” Phillips, 415 F.3d at 1318.
4
However, extrinsic evidence is generally thought less reliable than the patent and prosecution
history, id. at 1318-19; in essence, it is “less significant than the intrinsic record in determining
the legally operative meaning of claim language.” C.R. Bard, Inc. v. U.S. Surgical Corp., 388
F.3d 858, 862 (Fed. Cir. 2004) (quotation omitted).
III.
LEGAL DISCUSSION
First, the Court will address Lupin’s contention that the general limitation of “sustained
release formulations that possess both a pH-dependent and pH-independent binder in admixture”
(hereinafter referred to as “the pHd-pHi binder limitation”) must be applied to all claim terms of
the patents-in-suit. The Court will then address each of the following specific terms: (1) “pHdependent binder”; (2) “pH-independent binder”; (3) “binder”; (4) “admixture”; (5) “variant and
exercised-induced angina”; and (6) “fillers.”
a. “The pHd-pHi Binder Limitation”
Defendant argues that the specifications and prosecution histories of the patents-in-suit
restrict all claims to “sustained release formulations that possess both a pH-dependent and pHindependent binder in admixture.” (Lupin’s Opening Claim Construction Brief (“Lupin Opening
Br.”) at 6-11). In other words, Lupin argues that the pHd-pHi binder limitation must be read into
each and every claim of the patents in suit regardless of whether or not that exact language
appears in a particular claim. Plaintiffs argue that while some claims expressly require the pHdpHi binder limitation,2 it is improper to use the Applicants’ statements during the prosecutions of
the ‘607, ‘062, and ‘496 patents regarding these claims to restrict the scope of the claims of the
patents that do not expressly impose such a limitation, namely the ‘826, ‘328, ‘814, ‘724, and
‘258 patents. (Pl.’s Responsive Claim Construction Br. (“Pl.’s Responding Br.”) at 17).
2
The following patents expressly recite the pHd-pHi binder limitation: ‘607, ‘062, ‘911, and ‘057.
5
The Court begins its analysis by looking to the “actual words of the claim.” Becton,
Dickinson and Co. v. Tyco Healthcare Group, LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010). Here,
as stated above, although some of the claims of the patents-in-suit expressly recite the pHd-pHi
binder limitation, others do not contain such a limitation. Therefore, the actual claim language
does not support Lupin’s proposed general limitation for each and every claim.3
Having not identified the proposed general limitation in the claim language itself, the
Court moves to the specification “for guidance as to the meaning of the claims.” Phillips, 415
F.3d at 1317 (quoting Vitronics, 90 F.3d at 1582). The specification is “usually . . . dispositive . .
. [and] the single best guide to the meaning of a disputed term” and it may contain “an
intentional disclaimer, or disavowal, of claim scope by the inventor.” Id. at 1315-16. Here,
Lupin concedes that all of the patents-in-suit “share a substantially similar specification” and
cites only the ‘607 specification in support of its general limitation argument. (Lupin Opening
Br. at 2). Lupin does not, however, direct the Court to any language in any of the specifications
where the inventors restrict all claims to “sustained release formulations that possess both a pHdependent and pH-independent binder in admixture.” Moreover, the Court’s own review of the
‘607 specification does not reveal the pHd-pHi binder limitation. In fact, (1) the Summary of the
Invention does not refer to a pH-independent binder, (2) the specification teaches that pHindependent binders are not necessary, but rather that they are optional (see, e.g. ‘607 patent at
4:56-57: “pH-independent binders may be used in sustained release ranolazine oral dosage
forms”)(emphasis added), and (3) the preferred embodiments list pH-independent binders as
3
In fact, the Court finds that Lupin conceded all arguments pertaining the actual claim language when it identified
the only issues before the Court with respect to the proposed general limitation as being “[w]hether the specification
and prosecution history limits the scope of Asserted Patents to the only types of sustained release formulations that
Roche represented to the PTO would work and were inventive, namely: those formulations with both a pHdependent and pH-independent binder admixed together (where the latter ingredient also is not in the coating).”
(Lupin’s Opening Br. at 2).
6
optional excipients. (see, e.g., id. at 5:45-49 stating that “[t]he sustained release formulation may
also contain pharmaceutical excipients intimately admixed with the ranolazine and the pHdependent binder. Pharmaceutically acceptable excipients may include, for example, pHindependent binders or film-forming agents.”)(emphasis added). For these reasons, the Court
finds that the specifications of the patents-in-suit do not support Lupin’s proposed general
limitation.
Finally, the Court turns to the prosecution histories of the patents-in-suit to determine
whether they contain statements that narrow the scope of the claims. Phillips, 415 F.3d at 1317.4
Under the doctrine of prosecution disclaimer, a patentee may limit the meaning of a claim term
by making a clear and unmistakable disavowal of scope during prosecution. See Seachange Int’l,
Inc. v. C-COR Inc., 413 F.3d 1361, 1372-73 (Fed. Cir. 2005); see also Omega Eng’g, Inc. v.
Raytek Corp., 334 F.3d 1314, 1323-26 (Fed. Cir. 2003). This may occur, for example, when the
patentee explicitly characterizes an aspect of his invention in a specific manner to overcome
prior art. See Microsoft Corp. v. Multi-Tech Sys., Inc., 357 F.3d 1340, 1349 (Fed. Cir. 2004)
(interpreting “sending,” “transmitting,” and “receiving” limitations as requiring direct
transmission over telephone line when patentee stated that invention transmits over a standard
telephone line, thus disclaiming transmission over a packet-switched network). That said, a
patentee’s statements must be “both so clear as to show reasonable clarity and deliberateness,
and so unmistakable as to be unambiguous evidence of disclaimer.” Omega Eng’g, 334 F.3d at
1325 (internal citations omitted).
4
Here, it bears noting that “[b]ecause the prosecution history 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.” Phillips, 415 F.3d at 1317.
7
As a general rule, the prosecution of one claim term in a parent application–here, the ‘607
patent–will not limit different claim language in a continuation application. Invitrogen Corp. v.
Clontech Labs., Inc., 429 F.3d 1052, 1078 (Fed. Cir. 2005) (“[T]he prosecution of one claim
term in a parent application will generally not limit different claim language in a continuation
application.”); ResQNet.com, Inc. v. Lansa, Inc., 346 F.3d 1374, 1383 (Fed. Cir. 2003)
(“Although a parent patent’s prosecution history may inform the claim construction of its
descendent . . . prosecution history is irrelevant to the meaning of [a] limitation [if] the two
patents do not share the same claim language.”); Advanced Cardiovascular Sys., Inc. v.
Medtronic, Inc., 265 F.3d 1294, 1305–06 (Fed. Cir. 2001) (finding prosecution history of parent
patents to be irrelevant where “there are no common claims in dispute”); see also Alloc, Inc. v.
Int’l Trade Comm’n, 342 F.3d 1361, 1381 (Fed. Cir. 2003) (Schall, J., dissenting) (“Statements .
. . made during the prosecution of a parent application can only apply to continuation
applications if the parent and child patents contain the same claim limitations.”); Serrano v.
Telular Corp., 111 F.3d 1578, 1584 (Fed. Cir. 1997) (stating that “[t]he patentee’s statement
concerning whether the prior art discloses a ‘send’ signal means is relevant only to those claims
which require the generation of such a signal, and those claims are not asserted here” and
reasoning that “[a]lthough statements in a file history may of course be used to explain and
potentially limit the meaning of claim limitations, . . . [they] cannot be used to add an entirely
new limitation to the claim”); Ventana Medical Systems, Inc. v. Biogenex Laboratories, Inc., 473
F.3d 1173, 1182 (the court examines a patent’s prosecution history to “determine whether the
inventor disclaimed a particular interpretation of a claim term during the prosecution of the
patent in suit or . . . of an ancestor application. But the doctrine of prosecution disclaimer
generally does not apply when the claim term in the descendant patent uses different language.”).
8
An exception to this general rule applies where “an amendment to a related limitation in the
parent application distinguishes prior art and thereby specifically disclaims a later, though
differently worded, limitation in the continuation application.” Invitrogen Corp., 429 F.3d at
1078 citing Elkay Mfg. Co. v. EBCO Mfg. Co., 192 F.3d 973, 978-79 (Fed. Cir. 1999).
With this standard in mind, the Court will address the statements made during the
prosecutions of the ‘607, ‘062, and ‘496 patents which Lupin argues limit the scope of the claims
of the ‘826, ‘328, ‘814, ‘724, and ‘258 patents. The Court will address first the ‘607 patent
prosecution history and then turn to the prosecution history of the later filed continuing
applications, namely the ‘062 and ‘496 patent applications.
i. Prosecution history of the ‘607
Lupin asks this Court to refer to the prosecution history of the ‘607 patent when
construing claims in later filed patents, namely the ‘496, ‘826, ‘328, ‘814, ‘724, and ‘258 patents.
As stated above, the general rule is that that “[a]lthough a parent patent’s prosecution history
may inform the claim construction of its descendent . . . prosecution history is irrelevant to the
meaning of [a] limitation [if] the two patents do not share the same claim language.”
ResQNet.com, Inc., 346 F.3d at 1383.
Here, certain claims in certain patents in suit contain the pHd-pHi binder limitation
language, while others do not. In short, not all of the patents in suit share the same claim
language. Thus, the prosecution history of the ‘607 patent as it pertains to the pHd-pHi binder
limitation language is immaterial to the Court’s construction of the later filed patents to the
extent that the later filed patents do not contain the pHd-pHi binder limitation language. Id. The
Court declines to apply the prosecution history of the ‘607 patent to the claim construction of the
9
descendant patents absent a showing that the ‘607 patent and the particular descendant at issue
share the same claim language.
The Court also rejects Lupin’s argument that Plaintiffs restricted the scope of the patents
in suit to those that include a pH-independent and pH-dependent binder in admixture when they
distinguished the ‘607 patent over the prior art references of Dow and MacFarlane. Specifically,
Lupin argues that once a Patentee represents to the PTO that an invention is different from the
prior art because of a particular novel and essential feature, then every claim of the patent is
limited to the scope of that particular novel and essential feature. (See Jan. 19, 2012 Hr’ing
Trans. (“Hr’ing Tr.”) at pp. 111-114). Moreover, the Patentee cannot overcome that limitation in
later prosecutions unless the Patentee explicitly recants the limitation. (See Hr’ing Tr. at pp. 111114).
“[The Federal Circuit] recognizes an exception [to the general rule articulated above]
where an amendment to a related limitation in the parent application distinguishes prior art and
thereby specifically disclaims a later (though differently worded) limitation in the continuation
application.” Invitrogen Corp., 429 F.3d at 1078 citing Elkay Mfg. Co., 192 F.3d at 978-79.
Here, Plaintiffs agree that if they had represented to the PTO during the prosecution of the ‘607
patent that their invention as a whole required the pHd-pHi binder limitation, then all claims
would require said limitation. (See Hr’ing Tran. p. 139). However, Plaintiffs argue that the
prosecution history reveals that they did not make such a representation. The Court agrees.
In response to the PTO’s office action during the prosecution of the ‘607 patent
application, Plaintiffs distinguished the claimed inventions recited in claim 51 and 52 (which
later matured into Claims 1 and 2 of the ‘607 patent) from the pharmaceutical compositions
described in Dow and MacFarlane. Specifically, the Plaintiffs stated:
10
Dow does not describe or suggest the methods of claims 51-52 that use a sustained
release ranolazine dosage form that includes an admixture of a pH-independent
binder and a pH-dependent binder with ranolazine. More precisely, Dow does not
disclose a sustained release formulation [sic] having a pH-dependent binder. The
Examiner, in rejecting the pending claims acknowledged that Dow does not disclose
pH-dependent binders.
The MacFarlane reference does not provide the teaching missing from Dow et al.
namely a sustained release formulation including a pH-dependent binder in
combination with an admixture with a pH-independent binder. The MacFarlane
reference teaches against using pH-independent materials as binders in
pharmaceutical dosage forms as claims 51-52 require.
(Shear Decl. in Support of Pl.’s Opening Br. (“Shear Decl.”) at Exh. 13: April 6, 2001 Response
to October 13, 2000 Office Action at pp. 12-13). The plain language of these statements
demonstrates that they were limited to how Claims 51 and 52—and not the invention as a
whole—are distinguishable from Dow and MacFarlane. Even so, to obtain the ‘607 Patent,
Plaintiffs retracted all of the other claims that they sought during the initial application, but
reserved the right to pursue those claims in subsequent applications. This squares with Federal
Circuit precedent which permits patentees to broaden the claims of parent applications through
the filing of a subsequent application. See, e.g., Symbol Technologies, Inc. v. Lemelson Medical,
Education & Research Found., 422 F.3d 1378, 1385 (Fed. Cir. 2005) (“Commonly, and
justifiably, one might refile an application to add subject matter in order to attempt to support
broader claims as the development of an invention progresses.”).
Therefore, not only were Plaintiffs representations to the Examiner directed at the
particular language of claims 51 and 52 of the application which specifically contain the pHdpHi binder limitation—and not the invention as a whole—but Plaintiffs abandoned their pursuit
of the additional claims—thus clearly indicating to the Examiner that these arguments were not
directed at the retracted proposed claims.
As such, the Court finds that the doctrine of
prosecution disclaimer does not attach by way of the ‘607 patent prosecution history.
11
ii. Prosecution history of the later filed continuing applications
The Court now turns to Lupin’s prosecution disclaimer arguments as they relate the ‘062
and ‘496 patent applications.
The ‘062 Prosecution History: From the outset, the Court notes that the ‘062 patent
was prosecuted simultaneously with the ‘607 patent (see Pl.’s Responsive Br. at p. 6 fn.6) and
specifically requires the pHd-pHi binder limitation. (See ‘607 Patent, Cl. 1, supra¸at p. 2).
During the prosecution of the ‘062 patent application, the Examiner rejected the proposed claims
based on Dow and MacFarlane. In response, Plaintiffs distinguished the claimed inventions
from the pharmaceutical compositions described in Dow and MacFarlane in the following ways.
With respect to Dow, Plaintiffs explained that
Dow et al. does not describe or suggest the Applicants invention - - a sustained
release ranolazine dosage form that includes an admixture of a pH-independent
binder and a pH-dependent binder with ranolazine . . .
(Marx Decl. in Support of Lupin’s Opening Br. (“Marx Decl.”) at LA 127). And with
respect to MacFarlane, Plaintiffs stated that
MacFarlane is fairly understood by one of ordinary skill in the art to disclose
sustained release formulations that are prohibited from including pH-independent
material that is used as a binder in an admixture with a pH-dependent binder but
allows for the use of a pH-independent material as a coating for the dosage form.
(Id. at LA 128). Plaintiffs argued to the examiner that the proposed claims of the ‘062 patent—
claims that specifically require the admixed pHd-pHi binder limitation—were patentable over
the prior art references—Dow and MacFarlane—specifically because they required the pHd-pHi
binder limitation. (See, id., Oct. 12, 2000 Resp. to July 31, 2000 Office Action (LA119-LA124)
at pp. 1-2 (amended claim 31 and new claim 51); see also, Mar. 8, 2001 Resp. to Dec. 6, 2000
Office Action (LA125-LA131) at p. 1 (amended claim 31); see also Walsh Decl. in Support of
Pl.’s Resp. Br. at Exh. 26: Appl. No. 09/538,337 at pp. 42-44 (original claims 31-50)).
12
Plaintiffs’ arguments were tailored specifically to these particular claims. As such, the Court
finds that the doctrine of prosecution disclaimer does not attach by way of the ‘062 patent
prosecution history.
The ‘496 Prosecution History: Despite the fact that none of the claims of the ‘496
patent expressly require a ranolazine dosage form containing an admixed pHd-pHi binder, Lupin
argues that by distinguishing Dow during the prosecution of the ‘496 patent the Plaintiffs
restricted the scope of the claimed invention to one which requires a pHd-pHi binder limitation.
There are three components to Defendants argument.
First, Lupin contends that Plaintiffs
distinguished the claimed invention over the Dow prior art by stating that Dow did “not teach
any composition that would be capable of achieving the claimed method.” (Marx Decl. at LA
173). Second, Lupin contends that Plaintiffs represented to the PTO that the ‘496 patent teaches
only one formulation–“Formulation D”–that is capable of maintaining blood plasma levels
necessary for effective treatment in humans. (See, ’496 pat. at col. 10, l. 20 – col. 16, l. 21; see
also, Marx Decl. LA 166-6). And, third, “Formulation D” only works because it “includes a pHindependent binder in admixture with a pH-dependent binder.” (Marx Decl. at LA 155). In
short, Lupin contends that to achieve patentability over Dow during the prosecution of the ‘496
patent, Plaintiffs argued that their invention only worked because it included the pHd-pHi binder
limitation. Even assuming that this characterization is accurate, Lupin’s argument fails because
“a court may not read into a claim a limitation from a preferred embodiment, if that limitation is
not present in the claim itself.” BayerAG v. Biovail Corp., 279 F.3d 1340, 1348 (Fed. Cir. 2002)
(“While a court may look to the specification and prosecution history to interpret what a patentee
meant by a word or phrase in a claim, extraneous limitations cannot be read into the claims from
the specification or prosecution history.”)(internal citations omitted).
13
Here, because Lupin
concedes that the pHd-pHi binder limitation is not present in the claim itself, the Court cannot
read that limitation from the preferred embodiment, here “Formulation D,” into the claim.
To the extent that Lupin argues that the Applicants’ representations to the Examiner
during the prosecution of the ‘496 patent regarding MacFarlane qualify as disclaimer, the Court
disagrees. The applicants represented to the Examiner that the MacFarlane reference is not
pertinent to the ‘496 patent because MacFarlane discloses pharmaceutical compositions
including calcium channel blockers whereas the ‘496 claims are neither directed to
pharmaceutical compositions nor does ranolazine behave as a calcium channel blocker in the
treatment of angina. (Pl.’s Responding Br. 14). Plaintiffs told the PTO office that they were not
relying on pHd-pHi binder limitation to distinguish the MacFarlane reference as the MacFarlane
reference was utterly unrelated to the teachings of the ‘496 patent. (Id.). In the context of the
entire prosecution history, Plaintiffs statements regarding MacFarlane fall far short of the
specificity required by the standard. See, e.g., Omega Eng’g, at 1325 (a patentee’s statements
must be “both so clear as to show reasonable clarity and deliberateness, and so unmistakable as
to be unambiguous evidence of disclaimer.”). As such, the Court finds that the doctrine of
prosecution disclaimer does not attach by way of the ‘496 patent prosecution history.
In sum, the Court will not construe claims that do not specifically recite the pHd-pHi
binder limitation to include such a limitation because such a construction is not recited in the
claim language, is not supported by the specification, and the doctrine of prosecution disclaimer
does not attach.
14
b. Specific Terms in Dispute
The Court will now address each of the specific terms in dispute in turn, namely (1) “pHdependent binder”; (2) “pH-independent binder”; (3) “binder”, (4) “admixture”; (5) “variant and
exercised-induced angina”; and (6) “fillers.”
i. pH-dependent binder 5
The Court now turns the first disputed term: “pH-dependent binder”. Plaintiff proposes
“a binding material that affects the rate of release of ranolazine from a solid oral dosage form
into an aqueous environment based on the pH of that environment,” (Joint Claim Construction
Statement (“JCC”), Exh. B. at p. 14) whereas Lupin proposes “a ‘binder’ [i.e., a non-coating
pharmaceutical ingredient that serves to prevent rapid dissolution of the drug in a pharmaceutical
formulation] that affects the rate of release of ranolazine from a solid oral dosage form into an
aqueous environment based on the pH of that environment.” (Id.). Here, based on a side-by-side
comparison of the competing constructions, the parties agree that a pH-dependent binder “affects
the rate of release of ranolazine.” Therefore, the Court need only determine whether either or
both of Lupin’s additional restrictions must be applied, namely (1) “a non-coating
pharmaceutical ingredient” and (2) “that serves to prevent rapid dissolution.”
The Court begins by looking at the claim language itself. Vitronics Corp., 90 F.3d at
1582. For these purposes, Claim 2 of the ‘258 patent is illustrative.
The method of claim 1 wherein the sustained release dosage form includes at least
one pH dependent binder wherein the pH dependent binder inhibits the release of
ranolazine from the sustain release dosage from when the sustained release
dosage form is subjected to an aqueous environment having a pH of the stomach
and wherein the pH dependent binder promotes the release of a therapeutic
amount of ranolazine in an aqueous solution having a pH above about 4.5
5
The following patent claims recite “pH-dependent binder”: ’607 patent, Cl. 1; ’911 patent, Cls. 1, 3; ’057 patent,
Cls. 1, 8, 9; ’826 patent, Cls. 16, 18; ’328 patent, Cls. 1, 5, 6, 20; ’814 patent, Cls. 17, 19; ’724 patent, Cl. 12; ’258
patent, Cls. 2, 3, 8, 9, 11, 12.
15
See ’258 Patent, Claim 2. Nothing in the actual claim language suggests that the term pHdependent binder should be restricted to “a non-coating pharmaceutical ingredient that serves to
prevent rapid dissolution of the drug in a pharmaceutical formulation.”6 Therefore, the Court
must determine whether the specification and prosecution history support Lupin’s proposed
construction. Again, the parties’ proposed constructions share common language, namely “that
affects the rate of release of ranolazine from a solid oral dosage form into an aqueous
environment based on the pH of that environment” and, therefore, the Court need only address
Lupin’s two additional limitations. For ease of analysis, the Court will address these additional
limitations separately.
1. “a non-coating pharmaceutical ingredient”
To reiterate, the claim language does not suggest that pH-dependent binders are limited to
“non-coating pharmaceutical ingredient[s].” Therefore, the Court turns to the specification for
assistance.
Phillips, 415 F.3d at 1317.
The specification provides examples of both pH-
dependent binders and pH-independent binders that also function as coating agents. (See, e.g..
‘607 Patent at 4:25-34)(“Accordingly, the pH-dependent binders suitable for use in this invention
are those which inhibit rapid release of drug from a tablet during its residence in the stomach
(where the pH is-below about 4.5), and which promotes the release of a therapeutic amount of
ranolazine from the dosage form in the lower gastrointestinal tract (where the pH is generally
greater than about 4.5). Many materials known in the pharmaceutical art as ‘enteric’ binders and
coating agents have the desired pH dissolution properties.”). Thus, the specification suggests the
opposite of what Lupin’s proposed construction commands, namely that an ingredient used as a
pH-dependent binder may also be used as a coating agent. For this reason, Lupin’s construction
6
The parties agree that a pH-dependent binder “affects the rate of release of ranolazine.”
16
which would necessarily limit an ingredient used in the coating from functioning as a binder is
not supported by the specification.
Accordingly, because neither the claim language, nor the specification support limiting
pH-dependent binders to “non-coating pharmaceutical ingredients” the Court will not adopt this
element of Lupin’s proposed construction.7
2. “that serves to prevent rapid dissolution”
Again, because the claim language does not suggest that pH-dependent binders must
“serve[] to prevent rapid dissolution,” the Court turns to the specification “for guidance as to the
meaning of the claims.” Phillips, 415 F.3d at 1317 (quoting Vitronics, 90 F.3d at 1582). Here,
the specification provides that although pH-dependent binders inhibit rapid release in the
stomach (where there is a low pH) they increase release rates in the gastrointestinal tract
(where there is a high pH). See ‘607 4:19-25 and ‘826 patent at 4:43-49. In other words,
Lupin’s proposed construction is in direct conflict with the specification language which teaches
that in a specific environment—here, the gastrointestinal tract—pH-dependent binders promote
rapid dissolution. Therefore, the Court finds that the specification does not support Lupin’s
construction as it pertains to “rapid dissolution.” Accordingly, because neither the claim
language, nor the specification support limiting pH-dependent binders to those that “serve[] to
prevent rapid dissolution”, the Court will not adopt this element of Lupin’s proposed
construction.8
7
Because neither party references the prosecution history with respect to this proposed limitation on “pH-dependent
binder,” the Court will end its inquiry here.
8
Because neither party references the prosecution history with respect to this proposed limitation on “pH-dependent
binder”, the Court will end its inquiry here.
17
Having failed to find support for either element of Lupin’s proposed construction, the
Court adopts Plaintiffs’ proposed construction.
ii. pH-independent binder9
The Court now turns the second disputed term: “pH-independent binder.”
At oral
argument, Plaintiff proposed “a binding material that allows drug release at a rate independent of
pH”10 whereas Lupin proposes “a separate ‘binder’ [i.e., a non-coating pharmaceutical ingredient
that serves to prevent rapid dissolution of the drug in a pharmaceutical formulation] ingredient
that provides drug release at a rate independent of pH.” (JCC, Exh. B at p. 12). For these
purposes, Claim 1 of the ‘607 patent is illustrative.
A method for treating a human patient suffering from variant or exercise-induced
angina by administering a sustained release pharmaceutical dosage form
including at least 50% by weight ranolazine and an admixture of at least one pHdependent binder and at least one pH-independent binder wherein the
pharmaceutical dosage form is administered in no more than two tablets per dose
to the human patient to maintain ranolazine plasma levels in the human patient of
from about 550 to about 7500 ng base/mL for at least 24 hours wherein the dose
is administered at a frequency selected from the group consisting of once, twice
or three times over 24 hours and wherein the peak to trough plasma ranolazine
level does not exceed 3:1 over a 24 hour period.
‘607 Patent, Claim 1. The actual claim language does not suggest that the term pH-independent
binder should be restricted to “a non-coating pharmaceutical ingredient that serves to prevent
rapid dissolution of the drug in a pharmaceutical formulation.”11 Therefore, the Court must
9
The following patent claims recite “pH-independent binder”: ’607 patent, Cl. 1; ’911 patent, Cl. 1; ’057 patent, Cl.
1; ’826 patent, Cls. 16, 18; ’328 patent, Cls. 10, 20; ’814 patent, Cls. 17, 19; ’724 patent, Cl. 13; ’258 patent, Cl. 13.
10
Plaintiffs originally proposed the following construction: “a binding material that does not affect the rate of
release of ranolazine from a solid oral dosage form into an aqueous environment based on the pH of that
environment.” However, at oral argument, Plaintiffs proposed the above referenced “compromise.” The Court,
therefore, finds that Plaintiffs have withdrawn their original proposed construction.
11
A comparison of the competing construction reveals common language, namely “at a rate independent of pH.”
Therefore, because the parties agree to this piece of the construction, the Court need not examine it any further.
18
determine whether the specification and prosecution history support Lupin’s proposed
construction.
The parties’ proposed constructions share substantially common language, namely
“provides drug release at a rate independent of pH”12 and, therefore, the Court need only
address Lupin’s two additional limitations. For ease of analysis, the Court will address each
element of Lupin’s proposed construction separately.
1. “a non-coating pharmaceutical ingredient”
To repeat, the claim language does not suggest that pH-independent binders are limited to
“non-coating pharmaceutical ingredient[s].” The Court now turns the specification which teaches
that certain ingredients can potentially serve as binders and as coating materials. The ‘607 patent
specifically teaches that hydroxypropyl methylcellulose (“HPMC”) is an example of a pHindependent binder (see, ‘607 patent 5:48-50)13 that can also be used as an “optional filmforming agent” for coating the resulting ranolazine tablet. (Id. at 6:31-40).
Thus, the
specification suggests the opposite of what Lupin’s proposed construction commands, namely
that an ingredient used as a pH-independent binder may also be used as a coating agent. For this
reason, Lupin’s construction which would necessarily limit an ingredient used in the coating
from functioning as a binder is not supported by the specification.
12
The Court notes that the only difference between these portions of the parties’ proposed constructions is that
Plaintiffs’ proposal replaces “provides” with “allows.” At oral argument, Lupin did not specifically object to this
portion of the proposed construction. Moreover, Lupin did not seek to submit supplement argument regarding this
proposed construction. Because the parties have not identified an appreciable difference between “provides” and
“allows” the Court interprets these portions of the parties’ proposed constructions to be identical.
13
Although the cited language identifies HPMC as a pH-independent binder, certain portions of the intrinsic record
refer to HPMC as a pH-dependent binder. See, e.g., ‘607 patent, 5:57-63 (“It is to be noted that pH-dependent
binders and viscosity enhancing agents such as hydroxypropyl methylcellulose . . ..”). However, despite this
apparent inconsistency, for the purposes of this opinion, the Court will accept the parties’ representations that
HPMC is a pH-independent binder. See, e.g., Pl.’s Resp. Br. at pp. 17, 20, 21, and 23; see also, Lupin’s Opening Br.
at pp. 17, 18, and 27; see also, Hr’ing Tr. at p. 9, lns. 9-14).
19
Moreover, if the Court were to apply Lupin’s construction, then HPMC—which the
specifications explicitly identify as an optional pH-independent binder suitable for use in the
sustained release ranolazine dosage forms14—would not meet the “pH-independent binder”
limitation simply because it may also be used as a coating agent. In other words, accepting
Lupin’s construction would improperly exclude a preferred embodiment. In re Katz Interactive
Call Processing Patent Litig., 639 F.3d 1303, 1324 (Fed. Cir. 2011) (A claim construction that
excludes a preferred embodiment is rarely correct.); Chimie v. PPG Indus., Inc., 402 F.3d 1371,
1377 (Fed. Cir. 2005).
Having not found support for Lupin’s construction in either the claim language or the
specification, the Court now turns to the prosecution history. Here, Lupin relies on the doctrine
of prosecution disclaimer (See, infra., Section III. a.) and directs the Court to the following
statement as “a clear and unmistakable disavowal” of claim scope: “The pH-independent
material used in the Applicant’s invention is used as a binder and not as a coating.” (Shear Decl.
at Exh. 13: April 6, 2001 Response to October 13, 2000 Office Action at p. 14). When
considered in isolation, this statement seems to support Lupin’s argument. However, when
considering the full statement in concert with the specification’s teaching that a single
ingredient can serve as both a binder and as a coating material, this statement does not rise to
level of a “a clear and unmistakable disavowal” of claim scope limiting pH-independent binders
to “non-coating pharmaceutical materials.” The full passage states:
MacFarlane is fairly understood by one of ordinary skill in the art to disclose
sustained release formulations that are prohibited from including pH-independent
material that is used as a binder in an admixture with a pH-dependent binder but
allows for the use of a pH-independent material as a coating for the dosage form.
New claims 51 and 52 are all drawn to a method for treating angina that includes
the use of pharmaceutical dosage forms that include an admixture of a pH14
See, ’607 patent at 4:59.
20
independent binder and a pH-dependent binder. The pH-independent material
used in the claimed compounds is used as a binder and not as a coating. Contrary
to the teachings of MacFarlane et al., the Applicants have found that sustained
release formulations that include an admixture of a pH-independent binder and
pH-dependent binder in the bulk formulation provides good ranolazine dissolution
control.
(Marx Decl.‘607 Patent Response to Oct. 13, 2000 Office Action)(emphasis added). In other
words, the prosecution history reveals that the Applicants argued to the Examiner that the
MacFarlane reference teaches that pH-independent material may be used as a coating, but does
not teach that it can be used as binding material.
When read in conjunction with the
specification, which, as stated above, teaches that the same pharmaceutical material may be
used as both a binder and a coating, the Applicant’s statement to the Examiner can reasonably
be interpreted to argue that the invention at bar is patentable over the MacFarlane reference
because is teaches that pH-independent material can be in both a binder and a coating whereas
MacFarlane teaches that pH-independent material is only effective as a coating. See Elkay Mfg.
Co. v. Ebco Mfg. Co.,192 F.3d 973 (Fed. Cir. 1999) (“it is the totality of the prosecution history
that must be assessed, not the individual segments of the presentation made to the Patent and
Trademark Office by the applicant”). As such, the Court finds that this statement does not rise
to a level of a “a clear and unmistakable disavowal” of claim scope.
Accordingly, because the claim language, the specification, and the prosecution history
do not support limiting pH-independent binders to “non-coating pharmaceutical ingredients” the
Court will not adopt this element of Lupin’s proposed construction.15
15
To the extent that Lupin argues that the material cited by Plaintiffs is not in fact used as a binder but rather is used
as a coating said argument is more appropriate for the merits phase rather than the claim construction phase.
21
2. “that serves to prevent rapid dissolution”
The Court finds that the specification does not support Lupin’s proposed construction
that pH-independent binders “serve[] to prevent rapid dissolution.” This limitation does not
appear in the actual claim language and, in fact, the specification teaches that pH-independent
binders do not prevent dissolution. (See ‘607 patent at 4:47-63; ‘826 patent at 5:17-23) (pHindependent binders “do not themselves provide the required dissolution control provided by the
identified pH-dependent binders.”).
Accordingly, because the claim language and the
specification do not support limiting pH-independent binders to binders “that serve[] to prevent
rapid dissolution” the Court will not adopt this element of Lupin’s proposed construction.16
Having failed to find support for either element of Lupin’s proposed construction, the
Court adopts Plaintiffs’ proposed construction.
iii. Binder
Lupin contends that the term “binder” must be construed in isolation and defined by its
function within the formulation, namely a “non-coating pharmaceutical ingredient that is not
merely a filler or a dilutent, but prevents rapid dissolution of the drug from the formulation.”
(JCC, Exh. B, p. 4). In other words, Lupin’s proposed construction requires that all binders in
the formulation (1) prevent rapid dissolution of the drug; and (2) exclude any ingredient that may
also be used as a coating material. (Pl.s Resp. Br. 18). For the reasons stated above (See, infra,
Sections III.b.i & ii), the Court finds that a Lupin’s proposed construction of “binder” does not
find support in the claim language, the specification, or the prosecution history.17
16
Because neither party references the prosecution history with respect to this proposed limitation on “pHindependent binder,” the Court will end its inquiry here.
17
Lupin also argues that Plaintiffs’ inclusion of “binding material” in its proposed constructions “could lead to the
counterintuitive conclusion that an ingredient qualifies as a binder when that ingredient, in the context of the
formulation, is not really binding anything together at all (e.g., when an ingredient is acting as a coating or a mere
22
iv. Admixture18
The Court now turns to the fourth disputed term: “admixture.” Plaintiffs propose that the
Court apply the plain and ordinary meaning of “admixture” whereas Lupin proposes an
“[i]ntimate mixture of at least one pH-dependent binder and at least one pH-independent binder,
which are coprocessed by granulation and compression in the bulk formulation during the tablet
manufacturing process. Materials in the tablet coating are not in ‘admixture’ with materials in the
tablet core.” (JCC, Exh. B, pp. 14-15).
The Court looks first to the actual claim language. Here, the asserted claims reciting
“admixture” do not require that the ingredients in the admixture be “coprocessed by granulation
and compression in the bulk formulation during the tablet manufacturing process.” Moreover,
not all claims reciting “admixture” require that the admixture include “at least one pH-dependent
binder and at least one pH-independent binder.” (See, e.g., ’328 patent, Cls. 25, 27, 29, 31, 32).
Nor do all claims reciting “admixture” require that the admixture be part of a tablet. (See, e.g.,
’911 patent, Cl. 1; ’057 patent, Cl. 1; ’826 patent, Cls. 16, 18; ’328 patent, Cls. 25, 27, 29, 31,
32; ’814 patent, Cls. 17, 19).
Having failed to find support for each element of Lupin’s proposed construction in the
actual claim language, the Court turns to the specification and prosecution history. Lupin argues
that in order to overcome the prior art MacFarlane reference, Plaintiffs made several statements
to the Examiner that, under the doctrine of prosecution disclaimer, serve to limit the “claim
scope notwithstanding the ordinary meaning of the claim language.” (Lupin’s Responsive Br.
filler).” (Def. Opening Br. 21). Although Lupin’s argument is well taken, this argument is not suited for claim
construction, but rather for a decision on the merits.
18
The following patent claims recite “admixture”: ‘607 patent, Cl. 1; 911 patent, Cl. 1; ‘507 patent, Cl. 1; ‘826
patent, Cls. 16 and 18; ‘328 patent, Cls. 25-27, 29-32; and ‘814 patent, Cls. 17 and 19.
23
19). Specifically, Lupin argues that “during the prosecution of the ’607 patent, Roche explained
that while MacFarlane contained two ingredients from Roche’s list of a pH-dependent binder and
a pH-independent binder, the former was in the tablet core whereas the latter was in the coating.”
Id. In support of this argument, Lupin points to the following statement made by the Applicants
to the Examiner.
Contrary to the teachings of MacFarlane et al., the Applicants have found that
sustained release formulations that include an admixture of a pH-independent
binder and a pH-dependent binder in the bulk formulation provides a good
ranolazine dissolution control.
(Shear Decl. at Exh. 13: April 6, 2000 Response to Oct. 13, 2000 Official Action at p. 14; see
also, Mar. 8, 2001 Resp. to Dec. 6, 2000 Office Action (LA125-LA131) at 4). Lupin argues that
this statement is “so clear as to show reasonable clarity and deliberateness, and so unmistakable
as to be unambiguous evidence of disclaimer.” Omega Eng’g, 334 F.3d at 1325 (internal
citations omitted). Specifically, Lupin argues that Plaintiffs differentiated the claimed invention
from the MacFarlane prior art reference by explaining that although MacFarlane contained two
ingredients from Plaintiffs’ list of pH-dependent binders and pH-independent binders–the pHdependent binder was in the tablet core whereas the pH-independent binder was in the coating.
(Lupin Opening Br. at 26).
Plaintiffs, however, argue that these statements distinguishing the claimed invention as
patentable over MacFarlane cannot be read to redefine or disavow the plain and ordinary
meaning of “admixture,” but rather identify the elements of the patents in suit that are not present
in the MacFarlane reference. In support of this contention, Plaintiffs direct the Court to the
following statement made in response to the Examiner’s obviousness objection in light of the
MacFarlane and Dow prior art references.
The MacFarlane reference does not provide the teaching missing from Dow et al.
namely a sustained release formulation including a pH-dependent binder in
24
combination with an admixture with a pH-independent binder. The MacFarlane
reference teaches against using pH-independent materials as binders in
pharmaceutical dosage forms as claims 51-52 require. Because the claimed invention
encompasses pharmaceutical dosage forms that MacFarlane says will not work, (the
combination of a pH-dependent binder and a pH-independent binder) and because the
Dow reference does not disclose the use of pH-independent materials in a
pharmaceutical dosage form, the combination of MacFarlane with Dow do not render
claims 51-52 obvious.
(Shear Decl. at Exh. 13: April 6, 2001 Response to October 13, 2000 Office Action at p. 13). As
previously stated in this opinion, the doctrine of prosecution disclaimer “attaches only where an
application by amendment or by argument has ‘unequivocally disavowed a certain meaning to
obtain his patent.’ ” Schindler Elevator Corp., 593 F.3d at 1285. At bottom, Plaintiffs argued
that the proposed claimed invention encompassed teachings that MacFarlane said could not
work and include teachings not contained in Dow. Although Plaintiff’s argued that their claimed
invention was different from the prior art, their statements—when considered in totality—do not
necessarily—and certainly not unmistakably and unambiguously—disclaim the proposed
invention’s incorporation of the prior arts’ teachings.
1. “Formulation D” & Admixture
In further support of its proposed construction, Lupin directs the Court to “Formulation
D,” which describes the “intimate mixing” of pH-dependent binder and pH-independent binder
using a “granulation” and “compression” process, as an example of “a pH-independent binder in
an admixture with a pH-independent binder.” (Lupin’s Opening Br. 27). Lupin contends that
“Formulation D” is an exemplary process for making the claimed dosage forms and Plaintiffs
concede as much. (Pl.’s Opening Br. 17).
To the extent that Lupin argues that the exemplary process articulated in “Formulation
D” for making the claimed dosage form should limit the claims at issue to that specific
embodiment, the Court finds such an argument contrary to law. Phillips, 415 F.3d at 1323
25
(“[W]e have repeatedly warned against confining the claims to those [specific] embodiments.”);
see also CollegeNet, Inc. v. ApplyYourself, Inc., 418 F.3d 1225, 1231 (Fed. Cir. 2005) (“In
examining the specification for proper context, however, this court will not at any time import
limitations from the specification into the claims.”); see also SRI Int'l v. Matsushita Elec. Corp.,
775 F.2d 1107, 1121 n.14 (Fed. Cir. 1985) (“That a specification describes only one embodiment
does not require that each claim be limited to that one embodiment.”). Accordingly, the Court
rejects this argument.
v. “variant AND exercised-induced angina”19
The Court now turns the fifth disputed term: “variant and exercised-induced angina.”
Plaintiff proposes “a cardiovascular disease selected from variant angina and exercise induced
angina” whereas Lupin proposes “both (1) variant angina; and (2) exercise-induced angina.”
(JCC, Exh. B, pp. 18-19). Here, Claim 1 of the ’496 patent is illustrative:
A method for treating a human patient suffering from variant and exerciseinduced angina by administering a sustained release pharmaceutical dosage form
including at least 50% by weight ranolazine in no more than two tablets per dose
to the human patient to maintain ranolazine plasma levels in the human patient at
a minimum of 850 ng base/mL for at least 24 hours wherein the dose is
administered at a frequency selected from once, twice and three times over 24
hours.
(’496 patent, Cl. 1.).
Plaintiffs urge this court to correct what they characterize as a clerical error. (Pl.’s
Opening Br. 19). Plaintiffs cite to CBT Flint Partners, LLC v. Return Path, Inc., --- F.3d ---,
2011 WL 3487023 (Fed. Cir. Aug. 10, 2011) for the proposition that “in a patent infringement
suit, a district court may correct an obvious error in a patent claim.” Id. at *4 (Fed. Cir. Aug. 10,
2011). In Novo Indus., L.P. v. Micro Molds Corp., 350 F.3d 1348 (Fed. Cir. 2003), the Federal
19
The following patent claims recite “variant and exercised-induced angina”: ‘496 patent, Cl. 1; ‘826 patent, Cls. 1,
4, 6, 8, 10, 13, 15-18; ‘814 patent, Cls. 5, 7, 9, 11, 14, 16-19; and ‘724 patent, Cl. 14.
26
Circuit held that a District Court may correct an obvious error when “(1) the correction is not
subject to reasonable debate based on consideration of the claim language and the specification
and (2) the prosecution history does not suggest a different interpretation of the claims.” Id. at
1354.
However, the Court lacks authority to correct the alleged clerical error where, as here, the
error is not facially apparent, there are multiple correct interpretations, and the intrinsic evidence
does not provide clear direction. In Novo Industries L.P. v. Mocro Molds Corp., 350 F.3d 1348
the Federal Circuit reversed the district court’s attempt to “correct” claim language by construing
the word “a” to mean “and.” The Federal Circuit noted that when the “nature of the error is not
apparent from the face of the patent,” and there may be multiple correct ways of interpreting the
claim language, the intrinsic evidence lacked the “necessary clarity to overcome the ambiguity of
the claim.” Id. at 1357. Since under these circumstances “the district court was required to
guess as to what was intended” by the scope of the claims, correction via claim construction was
“beyond its authority.” Id. at 1358.
Here, if the term “and” in the claim language “variant and exercise-induced angina” were
construed to mean that a patient must have both conditions, as opposed to just one or the other,
the scope of covered conditions—and therefore infringing activity—will necessarily differ.
Thus, here, as in Novo, this Court lacks the authority to modify the claim language as a
“correction” of a clerical error because the intrinsic evidence does not provide the requisite
clarity to apply a correction that necessarily alters the scope of the claim. As such, the Court
adopts Lupin’s construction.
27
vi. Fillers
Dependent Claim 14 of the ‘724 patent recites: “The method of claim 12 wherein said
optional excipients comprise one or more of the following: fillers, coloring agents, flavoring
agents, plasticizers, or film-forming agents.” (emphasis added). Plaintiff proposes that the Court
apply the plain and ordinary meaning whereas Lupin proposes “a pharmaceutical excipient that
is not used as a binder.” (JCC, Exh. B, p. 21).
Logically, therefore, Lupin’s proposed
construction means, that if a particular pharmaceutical excipient is used as a binder, then it
cannot be used as a filler (and vice-a-versa, an excipient used as a filler, cannot be used as a
binder).
Plaintiffs’ expert and Lupin’s expert agree that the plain and ordinary meaning of “filler”
is “an excipient that adds bulk to a tablet.” (Pl.’s Resp. Br. 25, citing Chambliss Decl. at ¶ 50;
Davis Decl. at ¶ 39). And, Plaintiffs argue that the plain and ordinary meaning of “fillers” is
supported by the specification and argue that a person of ordinary skill in the art (“POSA”)
“would not exclude an agent as a ‘binder’ simply because it may also be used as a filler. Nor
would [a POSA] exclude an agent as a ‘filler’ simply because it may also be used as a binder.”
(Pl.’s Opening Br. 25).
Lupin, on the other hand, argues that plain and ordinary meaning must be modified based
on (1) the specification itself (Lupin Opening Br. at 23), (2) Plaintiffs’ own statements to the
FDA and the PTO (Id. at 23-24), and (3) Plaintiffs’ failure to show that the same excipient
actually performs two functions in the formulation (Lupin Resp. Br. 29). The Court will address
these three arguments in turn.
28
1. The Specification
Lupin argues that the specification indicates that Plaintiffs consider the term “filler” to
involve a different and distinct ingredient classification from “binders.” (Lupin Opening Br. at
24). Plaintiffs concede that “fillers” and “binders” are distinct categories of excipients by
function, but the particular ingredients can overlap by serving multiple functions within a given
formulation. (Lupin Resp. Br. at 29). Lupin’s argument that, in the context of the patents in suit,
“fillers” are distinct from “binders” based on the ingredients lists, is overcome by Plaintiffs’
identification of specific ingredients that can allegedly serve dual purposes within the same
formulation.
For instance, Plaintiffs cite to Claim 14 of the ‘724 patent which requires that fillers–if
present–be in addition to the “at least one pH-dependent binder” recited in Claim 12 of the ‘724
patent (but does not exclude other materials that may be used as binders from being used as
fillers). Additionally, the specification lists excipients that can be used as both fillers (See ‘724
patent 5:50-52) and “pH-independent binders or film-forming agents.” (See ‘724 patent 5:42-49).
The sustained release formulation may also contain pharmaceutical excipients
intimately admixed with the ranolazine and the pH-dependent binder.
Pharmaceutically acceptable excipients may include, for example, pHindependent binders or film-forming agents such as hydroxypropyl
methylcellulose, hydroxypropyl cellulose, methylcellulose, polyvinylpyrrolidone,
neutral poly(meth)acrylate esters (e.g. the methyl methacrylate/ethyl acrylate
copolymers sold under the trademark Eudragit NE by Rahm Pharmai, starch,
gelatin, sugars, carboxymethylcellulose, and the like. Other useful
pharmaceutical excipients include diluents such as lactose, mannitol, dry starch,
microcrystalline cellulose and the like.
(‘724 patent 5:42-52)(emphasis added). Plaintiffs have offered evidence that “diluents” are
synonymous with “fillers.”20 In the context of the asserted patents, the specification teaches that
same ingredients—here, starches and sugars such as lactose and mannitol—can be both binders
20
See, Shear Decl., Exh. 23: REMINGTON’S (17th ed 1985) at 1605-1606; see also, id., Exh. 24:
PHARMACEUTICAL DOSAGE FORMS, Vol. 1 – Tablets (1980) at 72-86.
29
and fillers (or diluents). Therefore, because the specification teaches that sugars and starches can
be both fillers and diluents, Lupin’s proposed construction is directly at odds with the
specification. As such, the Court finds Lupin’s argument unpersuasive.
2. Statements to FDA
Because neither party cites to authority standing for the proposition that the Court may
consider statements made to regulatory authorities–here, the FDA–for purposes of claim
construction, the Court will not consider these statements.
3. Actual Performance of a Dual Function
Lupin does not cite to any case law supporting its contention that Plaintiff’s must–at this
stage–present evidence of actual performance. The Court finds that this argument is not
appropriate for claim construction and in more squarely before the Court at the merits stage.
In sum, the Court finds that claim language, specification, and prosecution history do not
support departing from what the parties’ experts agree to be the plain and ordinary meaning of
the term “filler.” As such, the Court adopts Plaintiffs’ proposed construction.
IV.
CONCLUSION
For the aforementioned reasons, the Court construes the disputed terms of the patents-in-
suit as detailed above. An appropriate Order accompanies this Opinion.
/s/ Esther Salas
United States District Judge
March 21, 2012
30
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?