Alcon Laboratories, Inc. v. Allergan, Inc.
Opinion
Opinion
Carter, J.
ORDER GRANTING MOTION FOR SUMMARY JUDGMENT OF NONINFRINGMENT
Before the Court is Plaintiffs Alcon Laboratories, Inc., Alcon Research, Ltd., and Alcon Universal, Ltd.’s (collectively Alcon), and Bausch & Lomb, Inc.’s (Bausch & Lomb) motions for summary judgment in this declaratory judgment action. After reviewing the moving, opposing, and replying papers, after oral argument on Monday, March 17, 2003, and for the reasons set forth below, the Court GRANTS the motions.
I.
BACKGROUND
The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, was adopted by Congress to address the need to bring generic drugs to the market quickly and changed the way in which the Food and Drug Administration (FDA) approved the manufacture and use of new and generic drugs. See Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1568 (Fed.Cir.1997).
In order to market a new drug, the maker of the drug must obtain approval from the FDA. 21 U.S.C. § 355 (a). In order to obtain FDA approval, the maker must submit a New Drug Application (NDA) which includes extensive informa tion and testing of the new drug to insure its safety. See 21 U.S.C. § 355 (b). Once the…