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ASTRAZENECA AB v. MUTUAL PHARMACEUTICAL CO.

August 19, 2002

ASTRAZENECA AB, ET AL., PLAINTIFFS,
V.
MUTUAL PHARMACEUTICAL COMPANY, INC. DEFENDANT.



The opinion of the court was delivered by: Lowell A. Reed, Jr., Senior District Judge.

    CONCLUSIONS OF LAW REGARDING PATENT CLAIM CONSTRUCTION

Plaintiffs, Aktiebologet Hassle, KBI-E Inc., KBI Inc., AstraZeneca AB, and AstraZeneca LB, (collectively referred to as "Astra" or "plaintiffs") filed this patent infringement suit against defendant Mutual Pharmaceutical Company, Inc. ("Mutual" or "defendant"), alleging that under 35 U.S.C. § 271(e)(2), Mutual is infringing United States Patent No. 4,803,081 ("the '081 patent"), by filing its Abbreviated New Drug Application ("ANDA") seeking approval from the Federal Drug Administration ("FDA") to manufacture, use and sell Mutual's proposed Felodipine 10 mg, 5mg, and 2.5mg tablets products as generic versions of plaintiffs' products. The '081 patent is entitled "New Pharmaceutical Preparations With Extended Release," and deals with pharmaceutical extended release preparations of active compounds with very low solubility. In total, the following six claims of the '081 patent are at issue in this lawsuit: 8, 12, 14, 15 and 17.*fn1

A Markman hearing was held on April 30, 2002, in which the parties presented oral argument as to the proper construction of the disputed claim language in the claims at issue. The parties also submitted a series of briefs, deposition transcripts and proposed claim constructions to the Court, all of which were considered by this Court in making the claim constructions that follow. On each claim term to be construed, the parties have submitted many arguments and have pointed to many portions of the intrinsic and extrinsic record in their briefs, proposed claim constructions, and oral presentations. While the Court has considered all of the arguments and citations of the parties, I may not reiterate all of them in full for each claim term.

I. THE LAW OF PATENT CLAIM CONSTRUCTION

In general, a patent must describe the scope of the patentee's invention so as to "secure to [the patentee] all to which he is entitled, [and] to apprise the public of what is still open to them." Markman v. Westview Instruments, Inc., 517 U.S. 370, 373, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996) (internal quotation omitted) (alteration in original). This is accomplished through the specification of the patent, which should describe the invention in clear terms so that a person of ordinary skill in the art of the patent may make and use the invention, and the claims of the patent, which should "particularly point[] out and distinctly claim[] the subject matter which the applicant regards as his invention."*fn2 35 U.S.C. § 112.

In Markman, the Supreme Court, affirming the Court of Appeals for the Federal Circuit, held that construction of patent claims is exclusively within the province of the court to determine as a matter of law. 517 U.S. at 372, 116 S.Ct. 1384. To complete the task of claim construction, a court may draw on the canons of construction that can be sifted from the decisions of the Court of Appeals for the Federal Circuit spanning before Markman and beyond. In construing the claims of a patent, a court should consider the claim language, the specification, and, if offered, the prosecution history, which are collectively considered intrinsic evidence of the meaning of the claim terms. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed.Cir. 1995). As the public record before the United States Patent and Trademark Office ("PTO") upon which the public is entitled to rely, the intrinsic evidence is the most important source for determining the meaning of claim terms. See Vitronics Corporation v. Conceptronic, Inc., 90 F.3d 1576, 1582-83 (Fed.Cir. 1996). Under some circumstances, a court may also consult evidence extrinsic to the patent, such as technical dictionaries or expert testimony, to interpret the claims. See id. at 1583.

A. Claim Language

Claim construction begins by looking to the claim language itself to define the scope of the patent. See Bell Atlantic Network Services, Inc. v. Covad Comm. Group, Inc., 262 F.3d 1258, 1267 (Fed.Cir. 2001). A technical term used in a patent is construed as having "the meaning a person of ordinary skill in the field of the invention would understand it to mean." Id. Unless otherwise compelled, a court should give full effect to the ordinary meaning of claim terms, even if the terms are broad. See Johnson Worldwide Assoc., Inc. v. Zebco Corporation, 175 F.3d 985, 989 (Fed.Cir. 1999). The ordinary meaning of a term may be established through dictionary definitions. See CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed.Cir. 2002). "General descriptive terms will ordinarily be given their full meaning; modifiers will not be added to broad terms standing alone." Johnson Worldwide, 175 F.3d at 989. Where the claim language is clear on its face, the remaining intrinsic evidence is considered only to determine whether a deviation from that clear definition is specified. See Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed.Cir. 2001). Where the language lacks clarity, then the remaining intrinsic evidence is viewed for resolving that ambiguity. See id.

B. Specification

After examining the words of the claim, the court is directed to turn to the specification to determine whether any terms have been used in a manner which is inconsistent with the ordinary meaning. See Vitronics, 90 F.3d at 1582. While terms are generally given their ordinary meaning, "[c]laims must be read in view of the specification, of which they are a part." Markman, 52 F.3d at 979; see also Phonometrics, Inc. v. Northern Telecom Inc., 133 F.3d 1459, 1466 (Fed.Cir. 1998) ("Although claims are not necessarily restricted in scope to what is shown in a preferred embodiment, neither are the specifics of the preferred embodiment irrelevant to the correct meaning of claim limitations."). The relationship between the claims and the specification it illustrated by the following pair of claim construction canons: "(a) one may not read a limitation into a claim from the written description, but (b) one may look to the written description to define a term already in a claim limitation, for a claim must be read in view of the specification of which it is a part." Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1248 (Fed.Cir. 1998). At times, the line between reading a claim in light of its specification and reading a limitation into the claim from the specification is a fine one. See Interactive Gift, 256 F.3d at 1331. Thus, this Court is mindful that the specification is examined to discern the meaning of the claim as used by the patentee in the context of the entire invention and not merely to narrow the claim. See id.

While additional limitations may not be imported into a claim from the specification, a court may construe a limitation specifically recited in a claim in light of the specification. See Phonometrics, 133 F.3d at 1466. Thus, in order to inject a definition into a claim from the written description, the claim must explicitly contain a term in need of definition. See Renishaw, 158 F.3d at 1248, 1252 (noting that passages referring to the preferred embodiment cannot be read into the claim without some "hook"). Further, claim terms should not be narrowed by the content of the specification "unless the language of the claims invites reference to those sources." Johnson Worldwide, 175 F.3d at 990 (noting that there "must be a textual reference in the actual language of the claim with which to associate a proffered claim construction").

While there is a "heavy presumption" in favor of giving terms their ordinary meaning, the presumption can be overcome if (1) the patentee chooses to be his own lexicographer, or (2) a claim term so deprives the claim of clarity that there is "`no means by which the scope of the claim may be ascertained from the language used.'" Bell Atlantic, 262 F.3d at 1268 (quoting Jolt son Worldwide Assoc., Inc. v. Zebco Corp., 175 F.3d 985, 989 (Fed.Cir. 1999)). In the first situation, the court must examine intrinsic evidence to determine if the patentee gave a term an unordinary meaning. See id. The specification will act as a dictionary "`when it expressly defines terms used in the claims or when it defines terms by implication.'" Id. (quoting Vitronics, 90 F.3d at 1582). Thus, the specification is "highly relevant" and usually "dispositive" in construing claim terms. Id.

Where the specification is used to redefine the meaning of a particular term, the intrinsic evidence must "`clearly set forth'" or "`clearly redefine'" the term in such a way that one reasonably skilled in the art is on notice that the patentee intended such redefinition. Bell Atlantic, 262 F.3d at 1268 (quoting Elekta Instr. v. O.U.R. Scientific Int'l, 214 F.3d 1302, 1307 (Fed.Cir. 2000); N. Telecom,. Samsung, 215 F.3d 1281, 1287 (Fed.Cir. 2000)). The written description must demonstrate an "`express intent to impart a novel meaning' to claim terms." Id. (quoting Schering Corp. v. Amgen Inc., 222 F.3d 1347, 1353 (Fed.Cir. 2000); Optical Disc Corp. r. Del Mar Avionics, 208 F.3d 1324, 1334 (Fed.Cir. 2000)). Cf. Johnson Worldwide, 175 F.3d at 991 (term used in a variety of ways in specification may be indicative of breadth of term rather than a limited definition).

As to the second situation which may overcome a presumption that the term be construed to have its ordinary meaning, while a court generally construes claim terms consistent with their common meaning, a "common meaning, such as one expressed in a relevant dictionary, that flies in the face of the patent disclosure is undeserving of fealty." Renishaw, 158 F.3d at 1250. Also, a court may resort to the specifications if a claim term lends itself to several common meanings; in such a situation "the patent disclosure selves to point away from the improper meanings and toward the proper meaning." Id.

C. Prosecution History

This Court is also instructed to view the prosecution history to determine whether "the patentee has relinquished a potential claim construction in an amendment to the claim or in an argument to overcome or distinguish a reference." Bell Atlantic, 262 F.3d at 1268. This history encompasses the entire record of all proceedings before the PTO, including express representations made by the patentee regarding the scope of the patent, as well as prior art cited therein which may give clues as to what the claims do not cover. See id.; Vitronics, 90 F.3d at 1582-83. Thus this information can be of "critical significance" in construing the claims. Vitronics, 90 F.3d at 1582.

As with the specification, however, "[a]lthough the prosecution history can and should be used to understand the language used in the claims, it too cannot `enlarge, diminish, or vary' the limitations in the claims." Markman, 52 F.3d at 980 (quoting Goodyear Dental Vulcanite Co. v. Darvis, 102 U.S. 222, 227, 12 Otto 222, 26 L.Ed. 149 (1880)). A caveat: If a patentee takes a position before the PTO, such that a "competitor would reasonably believe that the applicant had surrendered the relevant subject matter," the patentee may be barred from asserting an inconsistent position on claim construction. Cybor Corp. v. FAS Tech., Inc., 138 F.3d 1448, 1457 (Fed.Cir. 1998); see also Cole v. Kimberly-Clark Corp., 102 F.3d 524, 531 (Fed. Cir. 1996) (holding that patentee was estopped from arguing that her "perforation means" encompassed "ultrasonic bonded seams" after she distinguished references that contained such seams). If a patentee distinguishes a reference on multiple grounds to the PTO, any one of these may indicate the correct construction of a term. See Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1477 n. * (Fed.Cir. 1998). However, "[u]nless altering claim language to escape an examiner['s] rejection, a patent applicant only limits claims during prosecution by clearly disavowing claim coverage," that is, by making a statement that concedes or disclaims coverage of the claims at issue based on a piece of prior art. York Products, Inc. v. Central Tractor Farm & Family Ctr., 99 F.3d 1568, 1575 (Fed.Cir. 1996).

D. Extrinsic Evidence

If the claims can be construed from the intrinsic evidence alone, it is not proper to rely on extrinsic evidence "other than that used to ascertain the ordinary meaning of the claim limitation." Bell Atlantic, 262 F.3d at 1258. In the rare circumstance that the court is not able to construe the claims after examining the intrinsic evidence, however, it may turn to extrinsic evidence to resolve any ambiguity. See id. Extrinsic evidence includes expert testimony, articles and testimony of the inventor. See id. As with the intrinsic evidence, extrinsic evidence may not be used to "vary, contradict, expand, or limit the claim language from how it is defined, even by implication, in the specification or file history." Id. It is also proper to consult extrinsic evidence for the purpose of understanding the underlying technology. See Interactive Gift, 256 F.3d at 1332.

Dictionaries and technical treatises, while they are technically extrinsic to the patent, hold a "special place" and in certain situations may be considered along with intrinsic evidence when determining the ordinary meaning of claim terms. Bell Atlantic, 262 F.3d at 1267. See also Dow Chem. Co. v. Sumitomo Chem. Co., Ltd., 257 F.3d 1364, 1372 (Fed.Cir. 2001); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1584 n. 6 (Fed.Cir. 1996) ("Judges are free to consult such resources at any time in order to better understand the underlying technology and may also rely on dictionaries definitions when construing term claims, so long as the dictionary definition does not contradict any definition found in or ascertained by a reading of the patent documents."). Courts are warned, however, against using non-scientific dictionaries, "`lest dictionary definitions . . . be converted into technical terms of art having legal, not linguistic significance.'" Sumitomo, 257 F.3d at 1372.

II. CONSTRUCTION OF THE CLAIMS

The claims here presented to the Court for construction may be categorized into the following groups: (1) Nonionic solubilizer (Claims 1, 8, 12, 14, 15 and 17); (2) Extended release (Claims 1, 8, 12, 14, 15 and 17); (3) A solution or dispersion of an effective amount of the active compound; and dissolving or dispersing an effective amount of the active compound (Claims 1, 8, 12, 14, 15 and 17); (4) hydrophilic gel system (Claims 12, 14 and 15); and (5) pharmaceutical dosage unit (Claim 17).

Astra argues that claim 10 is also asserted in this litigation. Mutual contends that Astra never identified this claim during fact discovery. (Astra's Final Answer to Mutual's Interrogatories Nos. 1, 5 and 7, Def.'s Ex. E at 3-10.) Astra brings forth no argument as to why this Court should allow Astra to pursue a claim which Astra does not deny was excluded ...


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