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Astrazeneca Ab, et al. v. Hanmi Usa

June 29, 2012


The opinion of the court was delivered by: Pisano, District Judge.


This is a Hatch-Waxman patent infringement action brought by Plaintiffs AstraZeneca AB, Aktiebolaget Hassle, AstraZeneca LP, KBI Inc. and KBI-E Inc. (collectively, "AstraZeneca" or "Plaintiffs") against defendants Hanmi, Inc., Hanmi Pharmaceutical Co., Ltd., Hanmi Fine Chemical Co., Ltd. and Hanmi Holdings Co., Ltd. (collectively, "Hanmi" or "Defendants"). Presently before the Court are five motions by Hanmi seeking summary judgment. The Court heard oral argument on three of the motions on June 20, 2012, and decides the remaining motions without oral argument pursuant to Federal Rule of Civil Procedure 78. This Opinion addresses two of the five pending motions -- those motions designated by the parties as Motion No. 1 and Motion No. 5. The remaining motions shall be addressed in a separate Opinion. For the reasons below, the Court denies Hanmi's Motions No. 1 and No. 5.


AstraZeneca is the holder of approved NDA No. 21-553 permitting the marketing and sale of AstraZeneca's esomeprazole magnesium product known as Nexium. Esomeprazole is the (--) or S enantiomer of omeprazole, which is a drug known as a proton pump inhibitor. Nexium is used for the treatment of four indications: treatment of gastroesophageal reflux disease (GERD); risk reduction of NSAID associated gastric ulcer; H. pylori eradication to reduce the risk of duodenal ulcer recurrence; and pathological hypersecretory conditions including Zollinger-Ellison syndrome. Hanmi has submitted New Drug Application No. 202342 to the United States Food and Drug Administration ("FDA") seeking approval to market esomeprazole strontium capsules in the United States to treat these same indications. Hanmi provided notice to Plaintiffs in December 2010 that it intends to market its esomeprazole strontium products before the expiration United States Patent No. 5,714,504 ("the '504 patent") and United States Patent No. 5,877,192 ("the '192 patent"), which are owned by Plaintiff AstraZeneca AB and listed in the FDA's Orange Book as covering the Nexium product and its uses. This lawsuit followed. The patents-in-suit cover pharmaceutical compositions containing alkaline salts of esomeprazole and methods of use thereof.


A. Legal Standard

1. Summary Judgment

A court shall grant summary judgment under Rule 56 of the Federal Rules of Civil Procedure "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). The substantive law identifies which facts are critical or "material." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A material fact raises a "genuine" issue "if the evidence is such that a reasonable jury could return a verdict" for the non-moving party. Healy v. N.Y. Life Ins. Co., 860 F.2d 1209, 1219 n.3 (3d Cir. 1988).

On a summary judgment motion, the moving party must show, first, that no genuine issue of material fact exists. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). If the moving party makes this showing, the burden shifts to the non-moving party to present evidence that a genuine fact issue compels a trial. Id. at 324. The non-moving party must then offer admissible evidence that establishes a genuine issue of material fact, id., not just "some metaphysical doubt as to the material facts." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986).

The Court must consider all facts and their logical inferences in the light most favorable to the non-moving party. Pollock v. American Tel. & Tel. Long Lines, 794 F.2d 860, 864 (3d Cir. 1986). The Court shall not "weigh the evidence and determine the truth of the matter," but need determine only whether a genuine issue necessitates a trial. Anderson, 477 U.S. at 249. If the non-moving party fails to demonstrate proof beyond a "mere scintilla" of evidence that a genuine issue of material fact exists, then the Court must grant summary judgment. Big Apple BMW v. BMW of North America, 974 F.2d 1358, 1363 (3d Cir. 1992).

B. Motion No. 1 - Non-Infringement Of U.S. Patent No. 5,877,192

In its first motion, Hanmi seeks judgment of non-infringement of claims 1-11, 13-18 and 20-23 of the '192 patent. A patent infringement analysis proceeds in two steps-the first is proper construction of the relevant claims, and the second is a comparison of those claims to the accused product or method. Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1288 (Fed. Cir. 2009). To prove infringement, the patentee must show that an accused product or method is within the claim limitations of the patent-in-suit either literally or under the doctrine of equivalents. See Amgen Inc. v. F. Hoffman-LA Roche Ltd, 580 F.3d 1340, 1374; Warner Jenkinson Co., Inc. v. Hilton Davis Chem. Co., 520 U.S. 17, 21, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997). "A patent is infringed if any claim is infringed ... for each claim is a separate statement of the patented invention." Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1220 (Fed.Cir.1995).

The '192 patent describes and claims a method for treating gastric acid related diseases with esomeprazole, and a method for the production of an esomeprazole-containing medicament for treating gastric acid related diseases. The claimed inventions are based on the discovery that esomeprazole has certain improved properties, and provides certain biological benefits, as compared to the prior art racematic compound omeprazole. For example, the inventors discovered that, compared to omeprazole, esomeprazole decreases the variation between individuals in plasma levels.

Those improved biological properties of esomeprazole versus omeprazole are reflected in the claims of the '192 patent. All of the claims at issue reflect at least one advantageous biological result as compared to omeprazole. By ...

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