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ABBOTT LABORATORIES v. IMPAX LABORATORIES

March 26, 2003

ABBOTT LABORATORIES, FOURNIER INDUSTRIE ET SANTE, LABORATORIES FOURNIER S.A. PLAINTIFFS,
v.
IMPAX LABORATORIES, INC. DEFENDANT.



The opinion of the court was delivered by: Joan B. Gottschall, United States District Judge

MEMORANDUM OPINION AND ORDER

Plaintiffs Abbott Laboratories ("Abbott"), Fournier Industrie Et Sante, and Laboratories Fournier S.A. (all three plaintiffs collectively "Fournier") have brought this patent infringement action against Impax Laboratories, Inc. ("Impax") alleging that Impax has infringed Fournier's United States Patent No. 4, 895, 726 (the '726 patent"). Before the court is defendant Impax's motion for partial summary judgment of non-infringement. For the reasons explained below, Impax's motion is granted.

Background

Plaintiffs are the owners and a licensee of the '726 patent. The '726 patent is directed to "a novel dosage form of fenofibrate containing fenofibrate and a solid surfactant*fn1 which have been co-micronized" and "to the method for the preparation of this dosage form and its use for improving the bioavailability in vivo." According to the patent, the invention proposed a novel therapeutic composition, containing fenofibrate and a solid surfactant that have been co-micronized, which is used in the oral treatment of hyperlipidemia and hypercholesterolemia. ('726 patent, col. 1, ll.4-10.) The medication is marketed by Abbott under the name TRICOR ® in 67 mg, 134 mg, and 200 mg dosage strengths. According to Foumier, the novelty of the invention derives from the fact that a co-micronized mixture of fenofibrate and a solid surtactant have better dissolution characteristics, and therefore better bioavailability, than separately micronized (or non-micronized) fenofibrate and surfactant which are mixed, but not micronized, together.

Defendant Impax is a manufacturer of generic drug products. Pursuant to the Hatch-Waxman Act, Impax filed an Abbreviated New Drug Application ("ANDA"), 21 U.S.C. § 355(j), seeking the Food and Drug Administration's approval to market a generic micronized fenofibrate product in three dosage forms: 67mg, 134mg, and 200mg. Impax's ANDA discloses that: (1) Impax uses premicronized fenofibrate in its products; and (2) at no time does Impax co-micronize fenofibrate and a solid surfactant in the absence of other cxcipients. (Impax 56.1(a)(3) St. at ¶¶ 52-59.) As part of the ANDA, Impax submitted a "Paragraph (IV)" certification referring to the '726 patent, stating "that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted."*fn2 21 U.S.C. § 355 (j)(2)(A)(vii)(IV). After receiving the required notices from Impax, Fournier filed three complaints — one for each of Impax's three proposed dosage forms — each asserting that Impax's fenofibrate product infringed the '726 patent. The three lawsuits were later consolidated as they all relate to the same issues.

The present dispute centers on the proper interpretation of the terms "co-micronized" and "co-micromzation" as used in claims 1 and 10 of the '726 patent. Claim 1 states:

A therapeutic composition, which is presented in the form of gelatin capsules and which is useful especially in the oral treatment of hyperlipidemia and hypercholesterolemia, said composition containing a co-micronized mixture of particles of fenofibrate and a solid surfactant, wherein the mean particle size of said co-micronized mixture is less than 15 p.m.
('726 patent, col. 5, 11. 6-12 (emphasis added).) Claim 10 states:
A method for improving the bioavailability to fenofibrate in vivo, which comprises co-micronization of the fenofibrate and a solid surfactant, the said co-micronization being carried out by micronization of a fenofibrate/solid surfactant mixture until the particle size of the powder obtained is less than 15 p.m.
(Id., col. 6, 11. 20-25 (emphasis added).) Fournier argues that Impax's product, which utilizes pre-micronized fenofibrate, infringes the '726 patent. Specifically, Fournier argues that Impax's product contains a mixture of fenofibrate and a solid surfactant that have been co-micronized, or reduced in size together. (Fournier Resp. at 2.) Although acknowledging that Impax's product starts with already mieronized (i.e., pre-micronized) Fenofibrate, Fournier argues that the fenofibrate in Impax's product is further micronized (i.e., co-micronized) with a surfactant during certain steps of the manufacturing process. (Id. at 5.)

The Novopharm Action

Based on the same claims at issue in this lawsuit, Fournier brought suit against Novopharm, a generie drug manufacturer, for infringement of the '726 patent. On March 20, 2002, Judge John W. Darrah granted Novopharm's motion for summary judgment of non-inflingement of the '726 patent. Abbott Labs. v. Novopharm Ltd., Consolidated Nos. 00 C 2141, 00 C 5094 and 01 C 1914, 2002 U.S. Dist. LEXIS 4659, at *25-26 (N.D. Ill. Mar. 19, 2002). As in this case, the critical issue in Novopharm was the meaning of "co-micronized" and "co-micronization" as used in claims 1 and 10 of the '726 patent. Relying on the ordinary definitions of the prefix "co" and the word "micronize," the Novopharm court determined that "the ordinary meaning of the term `co-micronized' would be "to reduce to a fine powder [micronize] with or together."` Id. at * 17. The court held that "co-micronization" and "co-micronized" are distinct from "microriizing fenofibrate by itself." Id. at *25. The court further concluded that one skilled in the art reading the claims, specification, and prosecution history could conclude that the term "co-micronized" in claims 1 and 10 "mean[s] that fenofibrate and a solid surfactant have been micronized together in the absence of other excipients." Id. at *20-21. Finally, because Novopharm's product utilized fenofibrate that has been micronized by itself, and at no time are fenofibrate and a solid surfactant present in the absence of other excipients, the court granted Novopharm's motion for summary judgment of non-infringement. Id. at *25-26.

Analysis

Summary judgment is proper "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact that the moving party is entitled to a judgment as a matter of law," Fed.R.Civ.P. 56(c). The moving party has the initial responsibility of demonstrating the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). Summary judgment is proper when no "reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). Because the determination is a question of fact, summary judgment of infringement is proper if a reasonable jury could find that every limitation of the claims in question would be met by the products that Impax is likely to sell. Bei v. L & L Wings. Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998).

Summary Judgment of Non-Infringement in Patent Cases

An infringement analysis is a two-step process. The first step is determining the meaning and scope of the patent claims allegedly infringed, also known as claim construction. Mahurkar v. Arrow Int'l, Inc., 160 F. Supp.2d 927, 932 (N.D. Ill. 2001) (citing Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995)). Courts must construe the claims as a matter of law before turning to the second step, the factual application of those claims to the accused products. Summary judgment is appropriate where it is shown that the question of infringement can be ...


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