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Astrazeneca Ab, et al. v. Hanmi Usa

August 30, 2012

ASTRAZENECA AB, ET AL. PLAINTIFFS,
v.
HANMI USA, INC., ET AL. DEFENDANTS.



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

OPINION

In this 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"), Hanmi originally filed five motions seeking summary judgment. Two of the motions, those designated by the parties as Motion No. 1 and Motion No. 5, were previously decided by the Court. See Opinion and Order, D.I. 226, 227. This Opinion addresses the remaining three, specifically, those motions designated by the parties as Motion No. 2, Motion No. 3 and Motion No. 4. The Court heard oral argument on Motion Nos. 2 and 4, and it decides the remaining motion without oral argument pursuant to Federal Rule of Civil Procedure 78. For the reasons below, the Court denies Hanmi's motions.

I. BACKGROUND

A background summary is set forth in the Court's earlier Opinion and, therefore, need not be repeated here. See Opinion at D.I. 226. Facts relevant to each of the instant motions are set forth below.

II. SUMMARY JUDGMENT MOTIONS

A. Summary Judgment Standard

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. 2 -- Invalidity Of U.S. Patent No. 5,877,192 -- Claims 12, 19, 21, and 22 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. The '192 patent states that it issued from an application that was a continuation-in-part of U.S. Patent Application No. 08/376,512 filed January 23, 1995, later issuing as U.S. Patent No. 5,714, 504, which was a continuation-in-part of U.S. Patent Application No. 08/256,174 filed June 28, 1994, later issuing as United States Patent No. 5,693,818. As alleged by AstraZeneca, the "family tree" of the '192 patent can be summarized as follows:

● Swedish Priority Application SE 9301830-7 (filed May 28, 1993) → ● Patent Cooperation Treaty application ("PCT application") designated PCT/SE/00509, filed May 27, 1994 (" '509 application"), which published as WO '988 on December 8, 1994 →

● United States Patent Application (a national stage application under 35 U.S.C. § 371) No. 256,174 (the '174 application) filed June 28, 1994, later issuing as United States Patent No. 5,693,818 (the "'818 patent") →

● United States Patent Application No. 376,512 (the "'512 application") filed January 23, 1995, later issuing as the (the "'504 patent") →

● United States Patent Application No. 833,962 (the "'962 application") filed April 11, 1997, later issuing as the '192 patent.

Thus, according to AstraZeneca, the '192 patent claims priority to the applications leading to the '504 patent and the '818 patent.

Hanmi seeks summary judgment that claims 12, 19 and 21-22 (to the extent dependent on claims 12 and 19) of the '192 patent are anticipated and therefore invalid. Specifically, Hanmi alleges that claims 12, 19 and 21-22 are anticipated and invalid under 35 U.S.C. § 102(b) because each limitation of those claims is allegedly found in WO 94/27988, published December 8, 1994 ("WO '988"). Hanmi contends that the '192 patent is not entitled to claim the benefit of a filing date earlier than its April 1997 filing date, and, therefore, the WO '988 reference is a prior art reference that anticipates the disputed claims. AstraZeneca disputes that the WO '988 is a prior art reference.

1. Legal Standards a. Anticipation

A patent is invalid if "the invention was patented or described in a printed publication in this or a foreign country . more than one year prior to the date of the application for patent in the United States." 35 U.S.C. § 102(b). If "each and every limitation is found either expressly or inherently in a single prior art reference," then a claim is invalid under § 102 for anticipation. Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1375 (Fed. Cir. 2006) (quoting Celeritas Techs. Ltd. v. Rockwell Int'l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998)). Anticipation is a question of fact that must be established by clear and convincing evidence.

Sanofi--Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). Although a fact question, summary judgment of anticipation may be appropriate if there is no genuine dispute of any material fact. Encyclopaedia Britannica, Inc. v. ...


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