DEY, L. P. et al v. TEVA PARENTERAL MEDICINES, INC. et al, No. 1:2009cv00087 - Document 99 (N.D.W. Va. 2011)

Court Description: MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS Signed by District Judge Irene M. Keeley on 6/17/2011. (Copy counsel of record)(kd)

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IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF WEST VIRGINIA DEY, L.P., and DEY, INC., Plaintiffs, v. // CIVIL ACTION NO. 1:09CV87 (Judge Keeley) TEVA PARENTERAL MEDICINES, INC., TEVA PHARMACEUTICALS USA, INC., and TEVA PHARMACEUTICAL INDUSTRIES, LTD., Defendants. MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS This patent infringement case involves four United States Patents issued to the plaintiffs, Dey L.P. and Dey, Inc. ( Dey ), including 6,667,344 ( the 344 patent ), 6,814,953 ( the 953 patent ), 7,348,362 ( the 362 patent ), and 7,462,645 ( the 645 patent ) (collectively, the patents-in-suit ). patents, entitled Bronchodilating The 344 and 953 Compositions and Methods, derive from provisional U.S. patent application 60/284,606, and share essentially identical specifications. The 362 and 645 patents, entitled Bronchodilating Beta-Agonist Compositions and Methods, derive 60/486,386. that from provisional U.S. patent application They too share essentially identical specifications closely resemble those of the 344 and 953 patents. The patents-in-suit cover aqueous compositions of formoterol, which allow the compositions to remain administration during long-term storage. suitable for direct They also cover methods DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS for using disorders. these compositions to treat broncho-constrictive Dey uses the formulations and methods described in these patents in a commercial product known as Perforomist®. I. In a letter dated BACKGROUND May 12, 2009, the defendants, Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical notified Dey Application that Industries, they ( ANDA ) had LTD. filed seeking (collectively, an United Abbreviated States Food Teva ), New Drug and Drug Administration ( FDA ) approval to market a generic formoterol fumarate inhalation solution 0.02 mg/2mL ( generic formoterol fumarate product ). Teva also filed a certification with the FDA alleging certain claims of the four patents-in-suit are invalid, unenforceable and not infringed by Teva s manufacture or sale of its generic formoterol fumarate product. Dey in response filed this patent infringement action against Teva pursuant the HatchWaxman Act (the Hatch-Waxman Act ). See 21 U.S.C. §§ 355, 360cc; 35 U.S.C. §§ 156, 271. Dey contends that the product described in Teva s ANDA infringes claims in the four patents-in-suit, specifically claims 1-14, 16-22, 27-31, 33-39, 48, 61-62, 65, and 69-74 of the 344 patent, claims 1-13, 15-21, 26-30, 32-38, 58-63, 74-86, 90-94, 992 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS 103, 105-111, and 131-136 of the 953 patent, claims 1-15 of the 362 patent, and claims 1-3, and 5-9 of the 645 patent (collectively, the asserted claims ). The parties have identified four terms and phrases from the asserted claims in need of construction for which they have proposed competing claim constructions. six agreed claim constructions. They also have submitted Following a claims construction hearing on March 3, 2011, and after considering the parties briefs and arguments, the Court adopts the following constructions. II. LEGAL STANDARDS The construction of patent claims presents a matter of law governed by federal statutes and the decisions of the Supreme Court of the United States and the United States Court of Appeals for the Federal Circuit. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995). When interpreting the meaning of a claim, a court may consider the claims, the specifications, and the prosecution histories as intrinsic evidence. Id. (quoting Unique Concepts, Inc. v. Brown, 939 F.2d 1558, 1561 (Fed. Cir. 1991)). According to a fundamental principle of claim construction, the invention itself, and the scope of a patentee s right of exclusion, will be defined by the patent s claims. See Phillips v. AWH Corporation, 415 F.3d 1303, 1312 (Fed. Cir. 2005) 3 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS (en banc) (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)); see also Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) ( [W]e look to the words of the claims themselves . . . to define the scope of the patented invention. ). The description of an invention in the claims, therefore, limits the scope of the invention. Id. Claim terms should be construed according to their ordinary and customary meaning, which 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. Id. at 1313. Claim construction therefore requires a court to determine how a person of ordinary skill in the art would have understood the disputed term or phrase in question. Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification. Id. When construing patent claims then, a court must consider the context of the unasserted claims. entire patent, Id. at 1314. including both asserted and Because a patent will ordinarily use patent terms consistently, the usage of a term in one claim can often illuminate the meaning of the same term in other claims. 4 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS Id. at 1314. Accordingly, [d]ifferences among claims can provide insight into understanding the meaning of particular claim terms, and the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim. Id. at 1314-15 (citing Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 910 (Fed. Cir. 2004)). Aside from the claims themselves, the specification in the patent often provides technical term. the best source for understanding a Id. at 1315 (quoting Multiform Desiccants,Inc. v. Medzam, Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998)). Pursuant to 35 U.S.C. § 112, ¶ 1, an inventor must use the specification to describe his claimed invention in full, clear, concise, and exact terms. Accordingly, [t]he claims of a patent are always to be read or interpreted in the light of its specifications. SchriberSchroth Co. v. Cleveland Trust Co., 311 U.S. 211, 217 (1940). An inventor may alter the ordinary and customary meaning of a term, however, by acting as his own lexicographer. This occurs, for example, when the patent specification defines a term in a manner different from its Phillips, 415 F.3d at 1316. ordinary and customary meaning. Thus, it is entirely appropriate for a court, when conducting claim construction, to rely heavily on the 5 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS written description for guidance as to the meaning of the claims. Id. at 1317. Nevertheless, a court may not import a limitation into the claims from the specification. Id. at 1323. Moreover, the Federal Circuit has repeatedly warned against limiting the claims to the embodiments specifically described in the specification. Id. In other words, a court should not construe the patent claims as being limited to a single embodiment simply because the patent describes only one embodiment. Id. (citing Gemstar-TV Guide Int l Inc. v. Int l Trade Comm n, 383 F.3d 1352, 1366 (Fed. Cir. 2004)). The prosecution history of a patent may also provide insight into the meaning of a term or phrase. Like the specification, the prosecution history provides evidence of how the PTO and the inventor understood the patent. Id. at 1317. The inventor s limitation of the invention during the patent s prosecution may suggest that a claim has a narrower scope than it otherwise might have. Id. Finally, when determining the ordinary and customary meaning of a term, a court must be cautious when considering extrinsic evidence, such as expert testimony, dictionaries, and learned treatises. Id. Nevertheless, such sources may be reliable if they were publicly available and show what a person of skill in 6 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS the art would have understood disputed claim language to mean. Id. at 1314 (quoting Innova, 381 F.3d at 1116). It is with these legal principles in mind that the Court turns to the construction of the four disputed terms or phrases among the asserted claims of the patents-in-suit. III. A. Formulated at administration a ANALYSIS concentration suitable for direct Dey proposes that the phrase formulated at a concentration suitable for direct administration, as used in claim 1 of the 344 patent and claim 74 of the 953 patent means ready to administer directly to diluting. 1 a subject in need thereof, without mixing or Teva construes the phrase to mean the composition is formulated at a concentration that is capable of being administered directly to a subject in need thereof. According to Dey, its proposed construction is supported by the claims, the specifications, the prosecution histories of the patents-in-suit, and the inventors sworn deposition testimony. It argues that Teva s proposed construction improperly treats capable 1 Initially, Dey proposed the following construction: ready to administer directly to a subject in need thereof, without mixing or diluting, at a free-base concentration of about 5 µg/mL to about 2mg/mL. It has since, however, withdrawn the last phrase. See Transcript of Record at 10-11, Dey, et al. v. Teva, et al., No. 1:09CV87 (N.D.W. Va. Mar. 3, 2011) (dkt. no. 95). 7 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS of as a synonym for suitable for. Teva claims that the intrinsic evidence supports its proposed construction, and that Dey has impermissibly added limitations that have no intrinsic basis. 1. The Claims According to Dey, the claims themselves support its proposed construction because the ordinary meaning of the term formulated is made, manufactured, fabricated. devised, composed, produced, or Pl. s Opening Claim Construction Report at 5 (citing Cambridge Dictionary of American English 339 (Cambridge University Press 2000) (dkt. no. 69-5) (dkt. no. 69). Teva, however, argues that the phrase without mixing or diluting in Dey s proposed construction improperly shifts the claim s focus from the time of the composition s manufacture to the time after formulation, which Teva contends formulated is at irrelevant a to whether concentration the composition suitable for was direct administration. Def. s Rebuttal Report at 10 (dkt. no. 76). Teva that also argues Dey s construction renders the claims indefinite because a person of ordinary skill in the art could only know if another composition infringed Dey s composition by discovering how the composition is used. See IPXL Holdings, L.L.C. v. Amazon.com, Inc., 430 F.3d 1377, 1384 (Fed. Cir. 2005) (holding that a claim is invalid when it is indefinite and fails to apprise 8 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS a person of ordinary skill in the art of its scope ). Dey denies that its proposed construction focuses on what happens to a composition after its formulation, claiming it clarifies how a composition must be created or made in order to be suitable for composition is direct administration. created or made to be It contends suitable for that a direct administration when it is ready to administer without the need for mixing or diluting. The claims themselves, unfortunately, fail to shed sufficient light on the meaning of this requirement. The Court therefore must look beyond the claims to the specifications and prosecution histories of the patents-in-suit to construe this phrase. 2. The Specifications According to Dey, the specifications provide intrinsic support for its proposed construction. A specification may define a claim term explicitly or by implication. Astrazeneca AB, Aktiebolaget Hassle, KBI-E, Inc. v. Mutual Pharm. Co., Inc., 384 F.3d 1333, 1339-40 (Fed. Cir. 2004). or description of the Moreover, [w]here the general summary invention describes a feature of the invention . . . and criticizes other products . . . that lack that same feature, this operates as a clear disavowal of these other products[.] Id. In any event, the claims cannot be of broader 9 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS scope than the invention that is set forth in the specification. On Demand Machine Corp. v. Ingram Industries, Inc., 442 F.3d 1331, 1340 (Fed. Cir. 2006). Here, the specifications describe the prior art of Hochrainer in U.S. Patent No. 6,150,418 ( Hochrainer ) as: a liquid active substance concentrate containing formoterol in the form of its free base, or in the form of one of the pharmacologically acceptable salts or addition products (adducts) thereof as active substance. 344, col. 7, ll. 65-67, col. 8., ll. 1-2. Hochrainer s formoterol concentrate as They also describe unsuitable for direct administration: The specification [of Hochrainer] provides . . . that it is the high concentration that allows for the stability of the concentrate. The liquid active substance concentrate is not suitable for direct administration to a patient. Id. at col. 8, ll. 7-10 (emphasis added). In contrast, the specifications in the 344 and 953 patents expressly provide that Dey s compositions are suitable for direct administration to a subject in need thereof. 24-29; 953, col 2, ll. 35-37. Id. at col. 2, ll. Dey argues that this distinction provides helpful insight for determining what a person of ordinary skill in the art would understand the phrase suitable for direct 10 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS administration to mean. See Arthur A. Collins, Inc. v. Northern Telecom Limited, 216 F.3d 1042, 1045 (Fed. Cir. 2000) (recognizing that a patentee s citation to the prior art can provide helpful guidance for determining a claim term s meaning to a person of ordinary skill in the art). The specification in Hochrainer provides that [t]he active substance concentrate according to the invention may be converted, by diluting with a pharmacologically acceptable Hochrainer, col. 1, ll. 47-49 (emphasis added). highly concentrated means a liquid. It clarifies that concentration of the active substance which is usually too high to enable the corresponding solution or suspension to be used therapeutically for inhalation without being diluted. Hochrainer also Id. at col. 2, ll. 1-4 (emphasis added). provides that [t]he active substance concentrate according to the invention is not usually suitable as such for direct medicinal use, and that [a] preferred method of converting the active substance concentrate into a pharmaceutical preparation suitable for administration is by diluting the active substance concentrate according to the invention pharmacologically suitable solvent or suspension agent. col. 4, ll. 9-11, 21-25. with a Id. at It also repeatedly provides that the active substance concentrate may be diluted by mixing it with a 11 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS diluent. See id. at col. 5, ll. 1-5, 20-27, 42-45, 57-67, col. 6, ll. 16-21. These properties compositions viewed establish that Hochrainer s the inventors formoterol of Dey s concentrate as unsuitable for direct administration because it usually needed to be mixed with a diluent prior to administration to a patient. Dey argues to persuasive effect that, because the 344 and 953 patents distinguish themselves from Hochrainer based on their suitability for direct administration, a person of ordinary skill in the art would understand that a composition is formulated at a concentration suitable for direct administration when it is ready to administer directly to a subject in need thereof, without mixing or diluting. 3. The Prosecution Histories Beyond the specifications and prior art, further support for Dey s proposed construction can histories of the patents-in-suit. be found in the prosecution See Ormco Corporation v. Align Technology, Inc., 498 F.3d 1307, 1314 (Fed. Cir. 2007). Like the specification, the prosecution history provides evidence of how the PTO and the inventor understood the patent. Phillips, 415 F.3d at 1317; see also Sentry Prods., Inc. v. Eagle Mfg. Co., 400 F.3d 910, 915 (Fed. Cir. 2005) (holding that the prosecution history may 12 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS modify a claim term s scope if the patentee expressly disclaimed the prior art s subject matter). In its application for the 344 patent, Dey initially submitted the following as claim 1: 1. Dey, 344 A pharmaceutical composition, comprising formoterol, or a derivative thereof, in a pharmacologically suitable fluid, wherein the composition is stable during long term storage and the fluid comprises water. Application application for the (dkt. 953 no. patent, 69-6). it Similarly, initially in its submitted the following as claim 1: 1. A kit, comprising: (a) an aqueous composition comprising formoterol or a derivative thereof formulated for single dosage administration; and (b) a nebulizer. Dey, 953 Application (dkt. no. 69-10). Trademark Office rejected these claims The U.S. Patent and as anticipated by Hochrainer. In its response to this rejection, Dey added the phrase formulated at a concentration suitable for direct administration to a subject in need thereof to claim 1 in each patent: 1. (Amended) A pharmaceutical composition, comprising formoterol, or a derivative thereof, in a pharmacologically suitable fluid, wherein the composition is stable during long term storage, the fluid 13 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS comprises water, and the composition is formulated at a concentration suitable for direct administration to a subject in need thereof. Dey, Amendment at 2 (June 22, 2001) (dkt. no. 69-8) (emphasis added). 1. (Amended) A kit, comprising: (a) an aqueous composition comprising formoterol or a derivative thereof formulated at a concentration suitable for direct administration to a subject in need thereof, wherein the composition is stable during long term storage; and (b) a nebulizer. Dey, Amendment at 1 (May 3, 2002) (dkt. no. 69-12) (emphasis added). At the time it submitted its amended version of claim 1 for the 344 patent, Dey also stated: Hochrainer et al. discloses that it is the high concentration that allows for the stability of the concentrate. The cited reference does not disclose stable, aqueous compositions containing formoterol formulated at a concentration for direct administration to a subject in need thereof, as required by the instantly-claimed compositions. The highly concentrated active substance concentrate of the reference is not suitable for direct administration to a subject in need thereof. . . . 14 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS Thus, the active substance concentrate of Hochrainer et al. is merely a means for the storage of highly concentrated solutions of formoterol, and is not formulated at a concentration for direct administration to a subject in need thereof. Dey, Amendment at 14-15 (June 22, 2001) (dkt. no. 69-8) (emphasis added) (prosecution history for the 344 patent) (dkt. no. 69-8). Dey provided a similar response to the U.S. Patent and Trademark Office following rejection of the 953 patent application. Dey, Amendment at 8-10 (May 3, 2002) (dkt. no. 69-12) (prosecution history of the 953 patent). After receiving these responses, the examiners at the U.S. Patent and Trademark Office approved Dey s amended claims. Dey supported its construction during the claims construction hearing by analogizing Hochrainer s formoterol concentrate to frozen orange juice concentrate that must be mixed or diluted with water prior to being suitable for drinking. Dey then compared its own compositions to orange juice that may be consumed directly from a bottle, without the need for mixing or diluting. See Transcript of Record at 18, Dey, et al. v. Teva, et al., No. 1:09CV87 (N.D.W. Va. Mar. 3, 2011) (dkt. no. 95). vital difference that renders Dey contended that it is this its compositions of formoterol suitable for direct administration and therefore ready to use. 15 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS In response to this analogy, Teva pointed out that people commonly mix orange juice with vodka prior to consuming it. Id. at 73. According to Teva, vodka is suitable for direct consumption regardless of whether a person later mixes or dilutes it with orange juice, and because of this the phrase suitable for direct administration would not preclude an diluting or mixing Dey s compositions. end user from further According to Teva, Dey s focus on how the compositions must be used prior to administration renders the patents indefinite. See IPXL Holdings, 430 F.3d at 1384. While Teva is correct that the construction of the phrase formulated at a concentration suitable for direct administration does not hinge on what happens to the compositions after formulation, its argument is ultimately unpersuasive. The disputed phrase begins with the term formulated, and there is no indication in the intrinsic evidence that Dey modified the ordinary meaning of this term, which commonly means created. 2 See Phillips, 415 F.3d at 1314 (citing Brown v. 3M, 265 F.3d 1349, 1352 (Fed. Cir. 2001) (recognizing that claim meaning will sometimes be readily apparent even to lay judges, and that claim construction 2 See also Cambridge Dictionary of American English 339 (Cambridge University Press 2000) (defining formulated ) (dkt. no. 69-5). 16 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS in such cases involves little more than the application of the widely accepted meaning of commonly understood words. ). In point of fact, the term formulated in the disputed phrase clarifies that suitability for direct administration turns on how the compositions must be created. Once the compositions are formulated in a way that renders them suitable for direct administration, it is irrelevant to the analysis what may happen to them afterward. Stated another way, the phrase formulated at a concentration suitable for direct administration does not restrict usage of the compositions after formulation but rather provides a guidepost for how the compositions must be formulated. Given that, the question becomes what properties and characteristics must the compositions possess in order to be formulated at a concentration suitable for direct administration? The repeated disavowal in the intrinsic evidence of the active substance concentrate of Hochrainer persuades the Court that Dey s compositions are suitable for direct administration because, unlike the prior art of Hochrainer s concentrate, they are formulated at a concentration that renders it unnecessary to mix or dilute them prior to administration. Thus, they are ready to use in the same way that liquid orange juice is ready to use, without diluting or mixing prior to consumption. 17 Once formulated, DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS it is irrelevant to Dey s compositions whether an end user mixes or dilutes them further because it is at the time of manufacture that they must be ready to administer, without mixing or diluting. Teva s proposed construction not only lacks evidentiary support, it also is not consistent with the intrinsic evidence. At bottom, it substitutes capable of for suitable for. Under that construction, the concentrate in Hochrainer also would be capable of direct administration because it could be so administered after mixing or dilution. Teva s construction, thus, fails to reconcile Dey s important disavowal of Hochrainer s formoterol concentrate in the intrinsic evidence, and conflicts with what a person of ordinary skill in the art would understand the disputed phrase to mean. In conclusion, although ready to administer directly and without mixing or diluting do not appear in either the 344 or 953 patents, the specifications and prosecution histories of these patents establish that a person of ordinary skill in the art would understand the phrase formulated at a concentration suitable for direct administration to mean that the compositions must be ready to use, and that the compositions are ready to use when they can be administered without diluting or mixing. at 1314. See Ormco, 498 F.3d The Court therefore adopts Dey s proposed construction 18 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS that a composition is formulated at a concentration suitable for direct administration when it is ready to administer directly to a subject in need thereof, without mixing or diluting. 3 B. Pharmaceutical composition Dey construes the term pharmaceutical composition, as used in claim 1 of the 344 patent, claim 74 of the 953 patent, claim 1 of the 362 patent, and claim 1 of the 645 patent, to mean a medicinal formulation excipients. containing an active drug and inert Teva construes it to mean a stable composition. Dey argues that the intrinsic evidence does not change or modify the plain and ordinary meaning of pharmaceutical composition, and that Teva s proposed construction inappropriately seeks to construe a preamble phrase. While Teva does not dispute that Dey s construction is the plain and ordinary meaning of the term, it claims the intrinsic evidence of the patents-in-suit establish that the inventors modified that meaning to include only compositions that are themselves intrinsically stable. Further, it argues the term constitutes a necessary antecedent that provides 3 Because the Court adopts Dey s proposed construction, it need not consider the testimony of the inventors. See Howmedica Osteonics Corp. v. Wright Med. Tech., Inc., 540 F.3d 1337, 1346-47 (Fed. Cir. 2008) (recognizing that consideration of inventor testimony is often inappropriate and unnecessary during claim construction). 19 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS structure for subsequent claim terms. There is a heavy presumption that a claim term carries its ordinary and customary meaning. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). This presumption does not apply, however, where the patentee acted as his own lexicographer and clearly set forth a definition of the disputed claim term in either the specification or prosecution history. Id. (citing Johnson Worldwide Associates, Inc. v. Zebco Corp., 175 F.3d at 990 (Fed. Cir. 1999)). To determine whether a disputed term has a definition different from its ordinary and customary meaning, courts may consider the claims, the specification, and the prosecution history. See Bell Atlantic Network Services, Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268-69 (Fed. Cir. 2001). 1. The Claims According to Teva, the term pharmaceutical composition provides a claim limitation of overarching stability that is distinct from the mere requirements of stability during long term storage and shelf life. imports an unwarranted Dey argues that this construction stability limitation where the term stable appears in the claims only in conjunction with the phrase stable during long term storage. 20 Further, because DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS pharmaceutical composition appears in preamble phrases, Dey contends it is a general term that does not limit the scope of the claims. Finally, Dey asserts the claims themselves support its construction of a pharmaceutical composition comprising an active drug, formoterol, and inert excipients, including a polar solvent, a tonicity adjusting agent, and a buffer. See, e.g., 344, cls. 1, 5, 7, 10. Generally, the preamble does not limit the claims. See Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354 (Fed. Cir. Sept. 13, 2010) (quoting Allen Eng g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002)). Therefore, to determine whether a preamble constitutes a substantive limitation, a court must evaluate the entire patent in order to understand the scope of the invention and the inventors intent as to the meaning and scope of the claims. See Catalina Mktg. Int l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quoting Corning Glass Works v. Sumitomo Electric U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989)). A preamble phrase does not constitute a substantive limitation when it states the invention s purpose or intended use, and the body of the claim completely defines the claimed invention. Id.; see also Biolitec, 299 F.3d at 1346 (quoting 21 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS Catalina, 289 F.3d at 809) (holding that [a] preamble is not regarded as limiting . . . [w]hen the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention. ). Nor does it constitute a substantive limitation when by using a descriptive name it identifies a complete invention set forth in the body of the claims. Id. (quoting IMS Tech., Inc. v. Haas Automation, Inc., 206 F.3d 1422, 1434-35 (Fed. Cir. 2000)). However, a phrase does constitute a substantive limitation if it includes essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim. Catalina, 289 F.3d at 808 (quoting Pitney Bowes, Inc. v. HewlettPackard Co., 182 F.3d 1298, 1309 (Fed. Cir. 1999)). In the patents-in-suit, the term pharmaceutical composition appears both as preamble phrases and also in the body of the claims. For example, the 344 patent describes a pharmaceutical composition as being comprised of: 1. . . . formoterol, or a derivative thereof, in a pharmacologically suitable fluid, wherein the composition is stable during long term storage, the fluid comprises water, and the composition is formulated at a concentration suitable for direct administration to a subject in need thereof. 344, cl. 1 (emphasis added) (preamble). 22 Similarly, the 953 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS patent describes [a] method for the treatment, prevention, or amelioration of one or more symptoms of bronchoconstrictive disorders, comprising administering an effective amount of a pharmaceutical composition to a subject in need of such treatment, wherein the pharmaceutical composition comprises formoterol or a derivative thereof formulated at a concentration suitable for direct administration to a subject in need thereof, in a pharmacologically suitable fluid, wherein the composition is stable during long term storage and the fluid comprises water. 953, cl. 74 (emphasis added) (body). Thus, to resolve whether the term pharmaceutical composition constitutes a life-giving limitation or a non-limiting and general description, the Court must review the patent as a whole. 2. See Catalina, 289 F.3d at 808. The Specifications Teva contends the specifications only describe pharmaceutical compositions that are themselves intrinsically stable. Further, it contends that the specifications contrast the prior art of Hochrainer to Dey s compositions based on stability, and also describe the other formulation excipients based on their stability as well. In pertinent part, the specifications state that [t]he compositions provided herein are stable solutions of a bronchodilating agent, or a derivative thereof, in a pharmacologically 23 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS suitable fluid that contains water, that are stable during long term storage. 344, col. 2, ll. 23-28 (emphasis added); 953, col. 2, ll. 32-35 (emphasis added). It is precisely because the specifications provide that the compositions are stable and stable during long term storage composition, that as Teva used in argues the the term pharmaceutical patents-in-suit, includes an overarching requirement of stability distinct from the requirement of merely being stable during long term storage. It also contends that the specifications themselves define this overarching requirement of stability: As used herein, the stability of a composition provided herein refers to the length of time at a given temperature that is greater than 80%, 85%, 90% or 95% of the initial amount of active ingredient, e.g., formoterol, is present in the composition. Thus, for example, a composition that is stable for 30 days at 25B C. would have greater than 80%, 85%, 90% or 95% of the initial amount of active ingredient present in the composition at 30 days following storage at 25B C. 344, col. 5, ll. 30-38; 953, col. 5, ll. 40-48. While Dey agrees that the compositions must be stable, it argues that this characteristic derives from the requirement that the compositions be suitable for direct administration. According to Dey, stability is not a characteristic that is inherent in the term pharmaceutical composition. It contends the 24 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS term itself implies no limitation of stability, and only appears in the claims as a general term. Dey also contends that Teva s suggested requirement of overarching stability fails to illuminate the term s meaning because the patents-in-suit do not establish durations or temperature limits for measuring it. Absent such context, Teva s stability requirement is meaningless in Dey s view. After careful consideration of the specifications, the Court concludes that the inventors did not define pharmaceutical composition to mean a stable composition with the reasonable clarity, deliberateness, and precision required when an inventor applies his own lexicography to a claim term. 30 F.3d 1475, 1480 (Fed. Cir. 1994). See In re Paulson, Whether it appears in the preamble of some claims, or in the body of others, the term provides only the general substantive limitation. context of the inventions, not a Compare 344, cl. 1 (preamble) with 953, cl. 74 (body). 3. The Prosecution Histories The prosecution histories of the patents-in-suit further undermine Teva s proposed construction. Teva contends that during the prosecution of the patents Dey argued that the stability of its compositions distinguished them from the prior art because Hochrainer does not disclose 25 stable, aqueous compositions DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS containing formoterol[.] Dey, Amendment at 14 (June 22, 2001) (dkt. no. 69-8) ( 344 prosecution history). Teva s emphasis on this excerpt from the prosecution history ignores the full context of Dey s argument, which includes the following: The cited reference does not disclose stable, aqueous compositions containing formoterol formulated at a concentration for direct administration to a subject in need thereof, as required by the instantly-claimed compositions. Id. (emphasis added). distinguished its Tellingly, as to the 344 patent, Dey never compositions from the prior art based on stability alone, but relied on stability coupled with suitability for direct administration. Dey also made this same distinction during the prosecution of the 953 patent. See Dey, Amendment (May 3, 2002) (dkt. no. 69-12) ( 953 prosecution history). While prosecuting the 362 patent, Dey acknowledged that Hochrainer s concentrations were stable, but distinguished its own compositions based on characteristics of stability coupled with their suitability for direct administration. Dey, Amendment (July 9, 2004) (dkt. no. 68-14) ( 362 prosecution history); see also Dey, Amendment at 12 (Mar. 23, 2007) (dkt. no. 71) (stating that, unlike the prior art of Hochrainer, the compositions of the 26 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS 362 patent would be stable during long term storage and be readyto-use ). Dey never asserted that its pharmaceutical compositions had an inherent characteristic of stability distinct from being stable during long term storage. The argument. prosecution histories, thus, fail to support Teva s The term pharmaceutical composition is a general one, and, as discussed, none of the intrinsic evidence supports a construction otherwise. The Court therefore adopts Dey s proposed construction that the term pharmaceutical composition means a medicinal formulation containing an active drug and inert excipients. C. Shelf life Dey construes the term shelf life, as used in claim 2 of the 344 patent, claims 2 and 75 of the 953 patents, claims 1-3 and 910 of the 362 patents, and claims 2-3 of the 645 patent, to mean the period of time during which a drug may be stored and remains suitable for use. 4 It points out that certain claims require the 4 The 344 and 953 patents use the term shelf-life, while the 362 and 645 patents use the term shelf life. Compare 344 patent, cl. 2; 953 patent, cl. 2 with 362 patent, cl. 1; 645 patent, cl. 2. This opinion will use the preferred dictionary form of the term, shelf life. See, e.g., Merriam-Webster s Third International Dictionary, Unabridged 2092 (Merriam-Webster, Inc., 3d ed. 2002); Merriam-Webster s Medical Desk Dictionary 740 (Merriam-Webster, Inc., 1996). 27 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS compositions to exhibit adequate shelf life, see 344 patent, cl. 2; 953 patent, cl. 75, and refutes Teva s contention that, because the claims themselves state the shelf life durations of the compositions, those durations define the term. See 344, cl. 2 (stating that the composition has an estimated shelf[]life of greater than 1 month usage time at 25E C and greater than or equal to 1 year storage time at 5E C. ); 953, cls. 2, 75 (same); 362 Patent, cl. 1 (stating that the composition has an estimated shelf life of greater than 90% after 3 months storage at 25E C and after 3 years storage at 5E C. ). Relying on Merriam-Webster s Medical Desk Dictionary, Dey asserts that the ordinary meaning of shelf life is the period of time during which a material (as a food or drug) may be stored and remains suitable for use. Merriam-Webster s Dictionary 740 (Merriam-Webster, Inc., 1996). that neither the claims, specifications, Medical Desk It further asserts nor the prosecution histories of the patents-in-suit modify this common definition. Notably, Teva does not propose a construction for the term shelf life. Rather, pointing to the claims, it argues that reliance on a dictionary definition is improper because the claims themselves provide the definition. See TAP Pharm. Prods., Inc. v. Owl Pharm., L.L.C., 419 F.3d 1346, 1354 (Fed. Cir. 2005) (reasoning 28 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS that a word describing patented technology takes its definition from the context in which it was used by the inventor. ). Teva also asserts that Dey is seeking to have the Court rewrite, not merely interpret, the plain language of the claims. as to claim 2 of the 344 patent, For example, it contends that the shelf life durations of 1 month usage time at 25E C, and greater than or equal to 1 year storage time at 5E C, constitute distinct requirements, which Dey s proposed construction improperly conflates by requiring that the composition be stored and remain suitable for use for more than 1 month usage time at 25E C and at least 1 year at 5E C[.] Def. s Rebuttal Brief at 20 (dkt. no. 76). The interpretation of a claim s meaning begins with how a person of ordinary skill in the art would understand it. Phillips, 415 F.3d at 1313 (citations omitted). See While extrinsic sources, such as technical dictionaries, can provide a court with an educational resource for determining how a person of ordinary skill in the art would understand a claim term or phrase, such sources are inherently less reliable than the intrinsic evidence. Id. at 1319. Thus, a court may never use a dictionary definition to alter the meaning of a claim provided by an intrinsic source. Id.; see also C.R. Bard, 388 F.3d at 862. When construing a commonly used term, however, a court may sometimes construe it by 29 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS applying its widely accepted meaning. Phillips, 415 F.3d at 1314 (citing Brown v. 3M, 265 F.3d 1349, 1352 (Fed. Cir. 2001)). Teva s contentions, that, first, the Court need not construe the term because the claims and specifications already define it, and, second, the definition of shelf life has separate requirements for usage time and storage time which Dey merges into one, are unavailing. The argument that the shelf life durations for storage time and usage time constitute distinct requirements fails to explain why these terms are distinct or why these purported distinctions are significant. Moreover, while contending that the Court need not construe the term, Teva fails to explain how the shelf life durations on which it relies define it. On this issue, the intrinsic evidence, unfortunately, is helpful. not Dey s construction, even though based on an extrinsic source, a medical dictionary, does provide a common definition establishing the significance of the shelf life durations cited by Teva, while neither modifying nor contradicting the intrinsic evidence. Its proposed construction also establishes that a composition stored at 5E C for 1, 2 or 3 years, see 344 patent, col. 6, ll. 66-67, col. 7, ll. 1-4, would remain suitable for use, a fact that could not otherwise be determined if the Court 30 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS does not construe the term. Dey s construction of shelf life, thus, is both consistent with the intrinsic evidence and also clarifies the significance of the shelf life durations. The Court therefore concludes that shelf life means the period of time during which a drug may be stored and remains suitable for use. D. Formulated for single dosage administration Dey construes the phrase formulated for single dosage administration, as used in claims 62, and 65 of the 344 patent, to mean formulated in a quantity that is taken or administered at one time. Teva s construction is the formoterol fumarate is formulated for single dosage administration via nebulization at a concentration of about 100 µg/mL. Neither party s arguments are grounded substantially in the intrinsic evidence; Teva relies exclusively on a single embodiment found in the specification, while Dey relies on extrinsic evidence to interpret the specification s examples and construe the disputed phrase. 1. The Claims Dey points out that Teva s construction would render claim 66 of the 344 patent internally inconsistent, and therefore invalid, because it would require a composition formulated for single dosage administration to have a formoterol concentration of about 31 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS 100 µg/mL. Claim 66 of the 344 patent provides: 66. An article of manufacture, comprising packaging material, the composition of claim 53 formulated for single dosage administration, which is useful for treatment, prevention or amelioration of one or more symptoms of diseases or disorders associated with undesired and/or uncontrolled bronchoconstriction[.] 344, cl. 66 (emphasis added). depends from claim 42. It depends from claim 53, which See Wahpeton Canvas Co., Inc. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed. Cir. 1989) ( a dependent claim includes all the limitations of the claim from which it depends. ). Claim 42 provides: 42. The pharmaceutical composition of claim 41, wherein the formoterol free base concentration is about 59 µg/mL. 344, cl. 42 (emphasis added). Because claim 66 depends from claims 53 and 42, the composition of claim 66, which is formulated for single dosage administration, must have a formoterol free base concentration of about 59 µg/mL. Teva concedes that its construction would render claim 66 internally inconsistent and invalid, but it argues that its construction is the only one that is consistent with the claim s 32 language and the written DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS description. 5 Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed. Cir. 1999). The Federal Circuit instructs that claims are generally construed so as to sustain their validity, if possible. Whittaker Corp. by Technibilt Div. v. UNR Industries, Inc., 911 F.2d 709, 711-12 (Fed. Cir. 1990) (citing ACS Hosp. Sys., Inc. v. Montefiore Hosp., 732 F.2d 1572, 1577 (Fed. Cir.1984)). This axiom only applies, however, when a claim s construction is consistent with the claim s language and the written description. at 1345. Rhine, 183 F.3d In other words, a court may not rewrite a claim to preserve its validity. Id. (citing Becton Dickinson & Co. v. C.R. Bard, Inc., 922 F.2d 792, 799 & n.6 (Fed. Cir. 1990)). Here, because the claims themselves provide little insight into the meaning of the specification disputed to phrase, determine the whether Court it must examine explicitly the defines formulated for single dosage administration as urged by Teva. 2. The Specification Dey relies on extrinsic sources to argue that examples from the specification support its construction that formulated for 5 As discussed earlier, although Dey does not assert claim 66, the Federal Circuit has instructed that both asserted and unasserted [claims] can . . . be valuable sources of enlightenment as to the meaning of a claim term. Phillips, 415 F.3d at 1314. 33 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS single dosage administration means formulated in a quantity that is taken or administered at one time. It points out that examples one and two disclose formulations with the same proportional concentrations of formoterol but different solution quantities. It then relies on extrinsic sources to establish that example two discloses single use formulations, and that this example establishes that formulation for single dosage administration turns on solution formoterol. quantity, not a specific concentration of Teva, on the other hand, argues simply that the specification provides an express definition for the disputed phrase because the only embodiment with a composition formulated for single dosage administration has a formoterol concentration of about 100 µg/mL. Dey points out that example one in the 344 patent describes two preparations of formoterol using a solution quantity of two liters of purified water: a low dosage strength formulation with a formoterol strength µg/mL.6 concentration formulation with See 344, Example 1. of a 85 µg/mL, formoterol and a high concentration dosage of 170 It refers to these preparations as 6 Example one describes the low dosage strength formulation as having 0.17 g of formoterol in two liters of water: 0.17 g formoterol / 2 L water = 0.085 g/L = 85 µg/mL. Example two also describes the high dosage strength formulation as having 0.34 g of formoterol in two liters of water: 0.34 g formoterol / 2 L water 34 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS bulk formulations. Like its bulk formulation counterparts, example two of the 344 patent describes unit dose formulations with low strength and high strength formulations that have the same proportional formoterol concentrations as the formulations in example one: 85 µg/mL, and 170 µg/mL, respectively.7 Id. at Example 2. Unlike the two liters of purified water needed for the bulk formulations, however, the unit dose formulations are prepared with the far smaller quantity of two milliliters of purified water.8 Because the specification does not define the term unit dose, or provide additional insight into its meaning, Dey relies on an extrinsic source, the FDA Compliance Policy Guide, § 430.100 (1984) (dkt. no. 77-2), to establish that a unit dose is a single dose. Further, relying on the Merriam-Webster s Medical Dictionary 218 (Merriam-Webster, Inc., 1996) (dkt. no. 69-19), it contends that a dose is the measured quantity of a therapeutic = 0.17 g/L = 170 µg/mL. 7 Example two describes the low strength unit dose as having 0.017 mg of formoterol in two milliliters of water: 0.17 mg formoterol / 2 mL water = 0.085 mg/mL = 85 µg/mL. Example two also describes the high strength unit dose as having 0.34 mg of formoterol in two milliliters of water: 0.34 mg formoterol / 2 mL water = 0.17 mg/mL = 170 µg/mL. 8 2,000 milliliters = 2 liters. 35 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS agent to be taken at one time. From these sources, Dey concludes that the unit dose formulations of example two are single doses that are formulated for single dosage administration because they are formulated in a quantity that is taken or administered at one time. Citing to Vitronics Corp. v. Conceptronic, Inc., Teva contends that Dey s reliance on extrinsic sources is improper because the specification provides an express definition that contradicts Dey s construction. observed that 90 F.3d at 1582. the plaintiff s In Vitronics, the Federal Circuit construction would prevent the specification s only embodiment from being covered by the claims. Id. at 1583. Given that [s]uch an interpretation is rarely, if ever, correct, and can only be sustained with highly persuasive evidence, the Federal Circuit rejected that construction, holding that the district court had relied improperly on extrinsic evidence providing a conflicting interpretation. In contrast construction here to is the Id. construction consistent with in the Vitronics, Dey s specification s embodiments and claims, while Teva s construction would render claim 66, which is formulated for single dosage administration, internally inconsistent and invalid since it obviously cannot have a formoterol concentrate of 59 µg/mL and 100 µg/mL. 36 See 344 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS patent, cls. 66, 53, 42. As discussed below, Teva fails to establish that the embodiment it cites defines the disputed phrase. Dey s construction, moreover, is consistent with the specification and would preserve the validity of claim 66. Although extrinsic evidence is disfavored and often unreliable, a district court is not forbidden from relying on it in all cases. Federal For example, in the landmark case of Phillips, the Circuit, sitting en banc, recognized that extrinsic evidence may be helpful in determining a reliable interpretation of patent claim scope when it is considered in the context of the intrinsic evidence. 415 F.3d at 1319. Thus, within the context of the intrinsic evidence, a district court may rely on extrinsic sources to educate itself regarding the field of the invention, or to determine what a person of ordinary skill in the art would understand claim terms to mean. Id. While an extrinsic source may never be used to contradict intrinsic evidence, the FDA Compliance Policy Guide relied on by Dey evinces a commonly understood meaning of the term unit dose that also comports with the intrinsic evidence. 1321. See id. at 1319, Therefore, when the definition of unit dose as a single dose is considered within the context of the specification and the claims as a whole, there being no intrinsic or extrinsic evidence 37 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS to the contrary, the Court concludes that Dey s reliance on an extrinsic source to define the unit dose formulations of example two as constituting single dose formulations is justified. Defining unit dose as a single dose, however, does not resolve whether single dose means single dosage. dosage have distinct, yet similar, meanings. Dose and According to Merriam-Webster s Third International Dictionary, Unabridged 676 (Merriam-Webster, Inc., 3d ed. 2002), a dose is the measured quantity of a medicine or other therapeutic agent to be taken at one time or in a period of time, while dosage is the amount of medicine or other therapeutic agent . . . prescribed or proper for a given patient or illness. Despite subtle differences, a single dosage reasonably may be understood as an amount of medicine prescribed to be taken or administered at one time - that is, a dose. In this context, the Court finds no meaningful distinctions between the ordinary meaning of the terms single dose and single dosage. Given the lack of a meaningful distinction between the terms, and given that the defining feature of the unit dose formulations in example two is solution quantity, Dey s proposed construction, that formulation for single dosage administration turns on a solution quantity to be taken or administered at one time, and not 38 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS a specific concentration of formoterol, is persuasive. While Teva correctly observes that the 344 patent does not expressly disclose whether a unit dose is formulated for single dosage administration, it does not dispute that a person of ordinary skill in the art would have had access to the FDA Compliance Policy Guide issued in 1984, and that, as defined in that guide, the terms unit dose and single dose are generally synonymous. between It also fails to identify any meaningful distinction the terms dose and single dosage. At bottom, therefore, Teva s contention that Dey s construction cannot be found in the text of the patent and that Dey s reliance on extrinsic evidence is improper, is unavailing. Teva contends that the specification expressly defines formulated for single dosage administration as: In one embodiment, the formoterol fumarate is formulated for single dosage administration via nebulization at a concentration of about 100 µg/mL. 344, col. 8, ll. 62-64. Because no other embodiments are described as being formulated for single dosage administration, it insists that Dey acted as its own lexicographer and defined claims 62 and 65 of the 344 patent as having formoterol concentrations of about 100 µg/mL. Fatal to this argument, however, is Teva s inability to 39 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS establish that Dey expressed a clear intent to define formulation for single dosage administration on the basis of a formoterol concentration of about 100 µg/mL. Although the only embodiment in the specification disclosed as being formulated for single dosage administration has a formoterol concentration of about 100 µg/mL, the specification includes no words or expressions of manifest exclusion or restriction establishing Dey s intent to limit and define the phrase as Teva construes it. I4I Limited Partnership, 598 F.3d at 843 (quoting Liebel-Flarsheim, 358 F.3d at 907-08). issue; To the contrary, the specification is ambiguous on this it formulated neither for states single nor implies dosage that all administration compositions must have a formoterol concentration of about 100 µg/mL. Well-settled principles of claim construction establish that the scope of patent protection will be defined by [t]he claims, not specification embodiments. Kara Technology Inc. v. Stamps.com Inc., 582 F.3d 1341, 1348 (Fed. Cir. 2009). Thus, a court may not limit the scope of the claims to a preferred embodiment or import a limitation from the specification into the claims. Phillips, 415 F.3d at 1323). Id. (citing Moreover, a claim generally will not be confined to the embodiments described in the specification unless the patentee has demonstrated a clear intention to limit 40 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS the claim s scope with words or expressions of manifest exclusion or restriction. I4I Limited Partnership v. Microsoft Corporation, 598 F.3d 831, 843 (Fed. Cir. 2010) (quoting LiebelFlarsheim, 358 F.3d at 907-08). Nothing in the 344 patent establishes that Dey used the embodiment to define the disputed phrase with reasonable clarity, deliberateness, and precision. In re Paulson, 30 F.3d at 1480. Mindful of the Federal Circuit s repeated warnings against limiting the scope of the claims to specific embodiments, the Court rejects Teva s proposal to limit Dey s claims in this manner. See Kara Technology, 582 F.3d at 1347. IV. CONCLUSION For the reasons discussed, the Court CONSTRUES the contested claim terms and phrases as follows: 1. Formulated at a concentration suitable for direct administration means ready to administer directly to a subject in need thereof, without mixing or diluting; 2. Pharmaceutical formulation composition containing an means active a drug medicinal and inert excipients; 3. Shelf life means the period of time during which a drug may be stored and remains suitable for use; and 41 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS 4. Formulated for single dosage administration means formulated in a quantity that is taken or administered at one time. Further, the Court adopts the parties agreed claim constructions and CONSTRUES the following terms and phrases as follows: 1. Stable during long term storage means the composition has an estimated shelf-life of greater than 1, 2 or 3 months usage time at 25° C and greater than or equal to 1, 2 or 3 years storage time at 5° C; 2. Article of manufacture means something that contains (1) packaging material, (2) a composition, which is useful for treatment, prevention or amelioration of one or more symptoms of diseases or disorders associated with undesired and/or uncontrolled bronchoconstriction, and (3) a label that indicates that the composition is used for treatment, prevention or amelioration of one or more symptoms of diseases or disorders associated with undesired and/or uncontrolled bronchoconstriction; 3. Packaging material or pharmaceutical packaging material means blister packs, bottles, tubes, inhalers, pumps, bags, vials, containers, syringes, bottles, and any 42 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS packaging material suitable for a selected formulation and intended mode of administration and treatment; 4. Label means Printed matter included with the article of manufacture that indicates that the composition is used for treatment, prevention or amelioration of one or more symptoms of diseases or disorders associated with undesired and/or uncontrolled bronchoconstriction. 5. Nebulizer/Nebulized means: Nebulizer : instrument that is capable of generating very fine liquid droplets for inhalation into the lung. Within this instrument, the nebulizing liquid or solution is atomized into a mist of droplets with a broad size distribution by methods known to those of skill in the art, including, but not limited to, compressed air, ultrasonic waves, or a vibrating orifice; Nebulized : a liquid or solution composition that has been atomized into a mist of droplets with a broad size distribution by an instrument that utilizes methods known to those of skill in the art, including, but not limited to, compressed air, ultrasonic waves, or a vibrating orifice; and 43 DEY, ET AL. V. TEVA, ET AL. 1:09CV87 MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS 6. Without dilution or other modification means a pharmaceutical composition that has not been diluted or changed in any other way. It is so ORDERED. The Court directs the Clerk to transmit copies of this Order to counsel of record. DATED: June 17, 2011. /s/ Irene M. Keeley IRENE M. KEELEY UNITED STATES DISTRICT JUDGE 44

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