The opinion of the court was delivered by: Michael Baylson, District Judge.
AstraZeneca AB (herein "Plaintiff") has brought this patent infringement action against Mutual Pharmaceutical Company, Inc. ("Defendant").*fn1 Presently before this Court is Plaintiff's Motion for Summary Judgment of Literal Infringement. For the reasons which follow, Plaintiff's Motion will be granted.
I. Background and Procedural History
On June 6, 2000, Defendant filed an Abbreviated New Drug Application ("ANDA") seeking approval from the Food and Drug Administration ("FDA") to manufacture and sell Defendant's proposed 10 mg generic version of felodipine. See Plaintiff's Memorandum in Support of its Motion for Summary Judgment of Literal Infringement (herein "Pl. Brief"), Ex. 31 (Nov. 15, 2000 letter from Mutual to FDA). Defendant amended its ANDA twice, to apply for approval of 5 mg and 2.5 mg dosages. See id.
Thereafter, on September 19, 2000, Plaintiff filed this patent infringement suit, alleging that the proposed drug formulations in Defendant's ANDA infringe the '081 patent. See 35 U.S.C. § 271(e)(2). Defendant counterclaimed, seeking declaratory judgments that its proposed formulations would not infringe the patent, and that the patent itself is invalid. On August 19, 2002, following a Markman hearing, this Court issued its Conclusions of Law regarding the proper construction of the patent claims at issue. Defendant then filed a motion for reconsideration, which this Court denied on October 3, 2002. On October 8, 2002, this matter was reassigned from the calendar of Judge Lowell A. Reed Jr. to the undersigned.
On October 25, 2002, Plaintiff filed its Motion for Summary Judgment of Literal Infringement. Defendant filed a brief in opposition and Plaintiff filed a reply brief. On January 30, 2003, this Court heard oral argument on Plaintiff's motion, and the parties have since submitted supplemental briefing.
II. The Law of Patent Infringement
The relevant statute makes it an act of patent infringement to file an ANDA,
if the purpose of such submission is to obtain
approval [under the Food, Drug and Cosmetic Act] to
engage in the commercial manufacture, use, or sale of
a drug or veterinary biological product claimed in
[the] patent or the use of which is claimed in [the]
patent before the expiration of such patent.
35 U.S.C. § 271(e)(2). The remedies for this type of infringement include injunctive relief against the Defendant's commercial manufacture, use, or sale of the drug. See id § 271(e)(4). A court may also order that the effective date of approval of the Defendant's new drug application be no earlier than the expiration of the infringed patent. See id. Monetary damages may not be awarded based on this type of infringement unless the Defendant has already commercially made, used, sold or offered to sell the drug. See id. Defendant admits that it filed its ANDA with the purpose of eventually selling a generic version of felodipine. See Defendant's Answer, Affirmative Defenses and Counterclaim ¶¶ 12-14. Defendant further admits that its ANDA contained a certification, as required by 21 U.S.C. § 355(j)(2)(A)(vii)(IV), declaring that Defendant's products would not infringe the '081 patent. See id. The question thus becomes whether the felodipine formulations described in Defendant's ANDA were claimed in the '081 patent.
Courts follow a two-prong analysis in determining whether a patent has been infringed. First, the court construes the scope and meaning of the claims within the patent itself, as a matter of law. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976-978 (Fed. Cir. 1995), aff'd 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Second, the court compares the claims of the patent to the allegedly infringing product, to determine whether it infringes the patent, either literally, or by equivalent parts. See, e.g., id.
In the first step, to ascertain the meaning of the patent's claims, the court must consider the language of the claims, the patent's specification, and the prosecution history. See id. at 979. The court may also rely on extrinsic evidence, such as dictionaries, learned treatises and expert testimony concerning the interpretation that those skilled in the relevant art would give to the claims. See id. at 980.
Terms within a patent claim must be interpreted according to "their ordinary meaning to one of skill in the art unless it appears from the patent and file history that the terms were used differently by the inventors." Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387 (Fed. Cir. 1992). As the Federal Circuit has recently explained,
This heavy presumption in favor of the ordinary
meaning of claim language as understood by one of
ordinary skill in the art is overcome: (1) where the
patentee has chosen to be his or her own
lexicographer by clearly setting forth an explicit
definition for a claim term; or (2) where the term
chosen by the patentee 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.
Prima Tek II, L.L.C. v. Polypap, S.A.R.L., 318 F.3d 1143, 1147-48 (Fed. Cir. 2003).
A patent's prosecution history consists of the public record of proceedings in the Patent and Trademark Office ("PTO"). See Markman, 52 F.3d at 980. Courts assess whether an inventor waived coverage of certain subject matter based on the totality of the prosecution history, including both claim amendments and arguments made to the PTO. See Rheox, Inc. v. Entact, Inc., 276 F.3d 1319, 1326 (Fed. Cir. 2002). The prosecution history can only limit claim language where the inventor surrendered coverage "with reasonable clarity and deliberateness." Schumer v. Laboratory Computer Systems, Inc., 308 F.3d 1304, 1313 (Fed. Cir. 2002).
In the second step of the two-prong process, the court compares the elements of the patent claims to the allegedly infringing product. The general rule is that a patent claim covers an accused device if that device embodies every element of the claim, either literally or by an equivalent element. See, e.g. Carroll Touch, Inc. v. Electro Mechanical Systems, Inc., 15 F.3d 1573, 1576 (Fed. Cir. 1993); Mannesmann Demag Corp. v. Engineered Metal Products, 793 F.2d 1279, 1282 (Fed. Cir. 1986). Plaintiff in the instant case is proceeding on a theory of literal infringement. To succeed, Plaintiff "must show that the accused device contains every limitation in the asserted claims. . . . If even one limitation is missing or not met as claimed, there is no literal infringement." Mas-Hamilton Group v. LaGard, Inc., 156 F.3d 1206, 1211 (Fed. Cir. 1998). See also Mannesmann, 793 F.2d at 1282. Though this infringement question is typically for the fact finder, see id., it becomes amenable to summary judgment where the parties do not dispute any relevant facts regarding the accused product, see, e.g., General Mills, Inc. v. Hunt-Wesson, Inc., 103 F.3d 978, 983 (Fed. Cir. 1997), or when the Court finds "no genuine issue as to any material fact" for trial. Fed.R.Civ.P. 56(c). An issue is "genuine," under Rule 56(c), if the evidence is such that a reasonable jury could return a verdict for the non-moving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).
A party seeking summary judgment always bears the initial responsibility for informing the district court of the basis for its motion and identifying those portions of the record that it believes demonstrate the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Where the non-moving party bears the burden of proof on a particular issue at trial, the moving party's initial burden can be met simply by "pointing out to the district court that there is an absence of evidence to support the non-moving party's case." Id. at 325, 106 S.Ct. 2548. After the moving party has met its initial burden, "the adverse party's response, by affidavits or as otherwise provided in this rule, must set forth specific facts showing that there is a genuine issue for trial." Fed.R.Civ.P. 56(e). Summary judgment is appropriate if the non-moving party fails to rebut by making a factual showing "sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Celotex, 477 U.S. at 322, 106 S.Ct. 2548. Under Rule 56, the Court must view the evidence presented on the motion in the light most favorable to the opposing party. Anderson, 477 U.S. at 255, 106 S.Ct. 2505.
III. Step One — Claim Construction
This Court has already completed the first step of the patent infringement analysis. See Conclusions of Law Regarding Patent Claim Construction (Aug. 19, 2002) (herein "Conclusions of Law"). In his August 19, 2002 opinion, Judge Reed ruled as to the meanings of several terms used in claims 1, 8, 12, 14, 15 and 17 of the '081 patent — the only claims at issue in this litigation. See id. at 1. Most of the terms interpreted by Judge Reed appear in claim 1 of the patent. Claims 2 through 16 are dependent on claim 1, which contains the following limitations:
1. A solid preparation providing extended release of
an active compound with very low solubility in water
comprising a solution or dispersion of an effective
amount of the active compound in a semi-solid or
liquid nonionic solubilizer, wherein the amount by
weight of the solubilizer is at least equal to the
amount by weight of the active compound, and a
release controlling system to provide extended
United States Patent 4,803,081 (issued Feb. 7, 1989) (emphasis added).
A. This Court's Claim Construction
In his Conclusions of Law Judge Reed construed the term "extended release," throughout the patent, as meaning "releasing the active ingredient from the dosage form over time in a manner that reduces the dosage frequency as compared to immediate release dosage forms." Conclusions of Law at 21. The Court interpreted the terms "solution or dispersion" and "dissolving or dispersing" according to their ordinary meanings, such that "a solution or dispersion is the dispersed or dissolved substance(s) and the medium in which it is dispersed or dissolved." Id. at 23. Next, the Judge interpreted "hydrophilic gel system," appearing in claim 12 of the patent, to mean "a delivery system of a water-soluble gel- and matrix-forming material." Id. at 24. Finally, the Court construed the term "pharmaceutical dosage unit," in claim 17, as meaning simply a dosage form, such as a tablet or capsule, containing a dose of a drug. Id. at 25.
2. "Nonionic Solubilizer"
Significantly, Judge Reed found that the ordinary meaning of "solubilizer" includes both "surfactants" and "co-solvents." Conclusions of Law at 10, 14, 19. Whether "solubilizer" in the patent includes co-solvents is important in this litigation, as Defendant's formulations allegedly include one particular co-solvent, polyethylene glycol 400 (herein "PEG 400").*fn2 See Pl. Brief, Ex. 20 (ANDA excerpt). Prior to Judge Reed's opinion, Defendant contended that "solubilizer" should be read to include surfactants, but not co-solvents. Defendant asserted that, in prosecuting the '081 patent, the inventor had waived co-solvents, such as PEG 400, as appropriate solubilizers for use in the invention disclosed in the patent.
Judge Reed considered the prosecution history, the patent specification and other intrinsic evidence, and found that the inventor had not clearly disavowed non-surfactant solubilizers. See Conclusions of Law at 19. While Judge Reed did not explicitly conclude that "solubilizer" within the patent covers the co-solvent PEG 400, he found that "solubilizer" does include co-solvents, generally.*fn3 Of course, any particular co-solvent, such as PEG 400, can only be considered a solubilizer, within a given device, if it functions as a solubilizer when it interacts with other components in that device. Thus, under Judge Reed's claim construction, the patent covers any co-solvent, within a particular drug formulation, if that co-solvent would function as a solubilizer within that formulation. Whether PEG 400 functions as a solubilizer in Defendant's products will be considered infra in Part IV.B.1.
Judge Reed also considered Defendant's argument that the inventor of the '081 patent disclaimed certain subject matter covered by a prior art patent, referred to herein as the "Kawata patent." See United States Patent 4,673,564 (issued June 16, 1987) (inventors, Hiroitsu Kawata, et al.). Defendant argued during claim construction that Plaintiff was only able to obtain the '081 patent by distinguishing the '081 patent's subject matter from Kawata.
The Kawata patent relates to "a sustained release pharmaceutical composition of a solid medical material." Id. (col.1, ln.17). Specifically, one object of the Kawata invention was to provide a sustained release pharmaceutical composition of the drug nicardipine, which has low solubility in the intestines. See id. (col. 2, lns. 14-16; col. 3, ln. 42). The Kawata invention is a process by which a solid medical material (i.e. nicardipine) is compounded with polyethylene oxide and at least one "basic substance" — the "first component" — such as, for example, hydroxypropylmethyl cellulose. Id. (col.1, lns.50-56). Kawata also teaches an optional second basic substance, the "second component." See id. (col.1, lns.66-68). Kawata suggests, only by way of example, that the second component may be a surfactant (also known as a "surface active agent"), or polyethylene glycol (i.e. PEG 400). See id. (col. 2, ln. 1; col. 5; ln. 65).
It is important to note that the Kawata patent actually teaches against the use of solubilizers. See id. (col.3, lns.49-52). As Kawata explains, the inventors "found that a sustained release pharmaceutical composition of nicardipine can be obtained by using amorphous nicardipine without adding any substance improving the solubility in the intestines." Id. Thus, although examples of the second component include surfactants and PEG 400, Kawata's process does not make use of these substances as solubilizers. Earlier in this litigation, at a Markman hearing, Judge Reed "specifically asked defendant to show where in the Kawata patent PEG 400 was used as a solubilizer. Defendant responded by directing the court to Example 2 and highlighting that PEG 400 is used; however, Mutual never explained how it is used as a solubilizer." Conclusions of Law at 16-17 (citation to transcript omitted).
Kawata describes a process in which the medical material and the first component (and, optionally, the second component) are dissolved in a volatile solvent such as ethanol, "singly or in combination," and then the volatile solvent is removed by drying. See id. (col.2, ln.24-30). The result is a fine powder in which the medical material is dissolved "uniformly in amorphous form in the basis substance(s)." See id. (col.2, lns.33-36). Finally, polyethylene oxide is mixed with the fine powder, resulting in a sustained release pharmaceutical composition. See id. (col.2, lns.36-39).
Defendant has placed great emphasis on the fact that Kawata lists PEG 400 as an example of the optional second component. Defendant argued before Judge Reed that, in order to obtain the '081 patent, Plaintiff disavowed the use of PEG 400, and other non-surfactant solubilizers, thereby limiting the '081 patent to surfactant type solubilizers. In response, Plaintiff argued that no such disclaimer had occurred, because Kawata and the '081 patent involve entirely different processes altogether. Specifically, Plaintiff contended, Kawata does not describe using PEG 400 as a solubilizer, and actually teaches against the use of solubilizers. See Conclusions of Law at 17-18. Rather, Plaintiff asserted that, in Kawata, the function of PEG 400 is to aid in Kawata's "co-precipitation" process, not to serve as a solubilizer. Id. at 16.
Based upon a thorough consideration of the Kawata patent and the prosecution history of the '081 patent, Judge Reed found that Plaintiff had not clearly disavowed non-surfactant solubilizers, such as PEG 400. See id. at 19. The Court held as follows:
[T]he prosecution history indicates that Astra did
not distinguish its patent from Kawata (1) on the
ground of a particular solubilizer because not only
does Kawata use an entirely different process, but
the specification teaches against solubilizers; and
(2) the claims do not require surfactant type
solubilizers because Kawata discloses both
surfactants and co-solvents as possibilities for the
optional second component. It is further noted that
Astra points out that nowhere in the prosecution
history did Astra define nonionic solubilizer as