Janssen Pharmaceutical N.V. v. Eon Labs Manufacturing, Inc. (374 F. Supp. 2d 263, 2004)

OPINION AND ORDER

GERSHON, District Judge.

Plaintiffs Janssen Pharmeceutica, N.V. and Janssen Pharmaceutica Products, L.P. (collectively “Janssen”) bring this action for patent infringement against Eon Labs Manufacturing Corporation, Inc. (“Eon”) pursuant to 35 U.S.C. § 271(e)(2). Jans-sen is the holder of a composition patent entitled “Beads Having a Core Coated with an Antifungal and a Polymer,” U.S. Patent No. 5,633,015 (“the ’015 patent”). Janssen markets this composition in a capsule under the name SPORANOX®. Eon, a generic drug manufacturer, filed an Abbreviated New Drug Application (“ANDA”) pursuant to Section 505(j) of the federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(j), seeking Federal Food and Drug Administration (“FDA”) approval to make and sell a generic version of the SPORANOX® capsule. The ANDA procedure for drug approval, created by the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L.No.98-417, 98 Stat. 1585 (1984) (codified in sections of titles 21, 35 and 42 U.S.C.) (“the Hatch-Waxman Act”), allows a generic manufacturer to avoid the costly and time-consuming safety and efficacy studies that were required of the brand name drug, so long as the generic drug is the bioequivalent of the FDA-approved drug. In its ANDA, Eon certified, pursuant to 21 U.S.C. § 355(j)(2)(A)(iv), that the ’015 patent was “invalid or will not be infringed by the manufacture, use or sale of the generic drug for which the ANDA is being submitted.” After Eon notified Janssen of its ANDA filing, Janssen filed this suit for patent infringement on April 13, 2001, and a 30-month automatic stay of FDA approval for Eon’s ANDA was imposed pursuant to 21 U.S.C. § 355(j)(5)(B)(iii).

On March 7, 2004, the extended stay of FDA approval expired. On March 16, 2004, I granted a temporary restraining order (“TRO”) to prevent Eon from marketing its generic product, should it receive FDA approval to do so, pending determination of Janssen’s motion for a preliminary injunction.

In an order dated April 6, 2004, I construed the only independent claim in the ’015 patent, Claim 1, and denied Eon’s motion for partial summary judgment. On April 8, 2004, Magistrate Judge Marilyn D. Go issued a report recommending that Janssen’s motion for summary judgment rejecting the affirmative defenses of invalidity and unenforceability be granted and that Eon’s motion for summary judgment based on the defense of invalidity be denied. Since the filing of objections and responses to Judge Go’s report was not completed until shortly before the trial, decision was withheld and the parties permitted to further develop facts at trial. The ’015 patent

The patent in suit concerns “a novel composition of antifungal agents which have low solubility in aqueous media, a process for preparing said composition and pharmaceutical dosage forms for oral administration comprising the novel composition.” ’015 Patent, col. 1, lines 10-15. This composition and the pharmaceutical dosage forms allow poorly soluble itracona-zole molecules to be delivered to a patient in an oral dosage form to treat fungal infections.

Claim 1 of the patent, the only independent claim, reads:

1. A bead comprising:

a.a central, rounded or spherical core;

b. a coating film of a hydrophilic polymer and an antifungal agent selected from the group consisting of itraconazole and saperconazole, and

c. a seal-coating polymer layer, characterized in that the core has a diameter of from about 600 to about 700