ESTHER 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) "pH-independent 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.
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"); 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.
See, '607 Patent, Cl. 1 (emphasis added to terms in dispute).
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 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."
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 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. 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).
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) "pH-dependent binder"; (2) "pH-independent binder"; (3) "binder"; (4) "admixture"; (5) "variant and exercised-induced angina"; and (6) "fillers."
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 pH-independent 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 pHd-pHi binder limitation,
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.
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 pH-dependent 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 pH-independent binders are not necessary, but rather that they are optional (see, e.g. '607 patent at 4:56-57: "pH-independent binders
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.
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."). 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.
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 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. 111-114).
"[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:
(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 pHd-pHi 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.
The Court now turns to Lupin's prosecution disclaimer arguments as they relate the '062 and '496 patent applications.
(Marx Decl. in Support of Lupin's Opening Br. ("Marx Decl.") at LA 127). And with respect to MacFarlane, Plaintiffs stated that
(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)). 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.
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.
The Court will now address each of the specific terms in dispute in turn, namely (1) "pH-dependent binder"; (2) "pH-independent binder"; (3) "binder", (4) "admixture"; (5) "variant and exercised-induced angina"; and (6) "fillers."
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.
See '258 Patent, Claim 2. Nothing in the actual claim language suggests that the term pH-dependent binder should be restricted to "a non-coating pharmaceutical ingredient that serves to prevent rapid dissolution of the drug in a pharmaceutical formulation."
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 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.
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
Having failed to find support for either element of Lupin's proposed construction, the Court adopts Plaintiffs' proposed construction.
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"
`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."
The parties' proposed constructions share substantially common language, namely "provides drug release at a rate independent of pH"
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 pH-independent binder (see, '607 patent 5:48-50)
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 forms
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:
(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.
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) (pH-independent 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.
Having failed to find support for either element of Lupin's proposed construction, the Court adopts Plaintiffs' proposed construction.
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.
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. 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.
(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 pH-dependent 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.
(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.
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 ("[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.
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:
('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 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.
Dependent Claim 14 of the '724 patent recites: "The method of claim 12 wherein said optional excipients comprise one or more of the following:
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.
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
(`724 patent 5:42-52)(emphasis added). Plaintiffs have offered evidence that "diluents" are synonymous with "fillers."
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.
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.
For the aforementioned reasons, the Court construes the disputed terms of the patents-in-suit as detailed above. An appropriate Order accompanies this Opinion.