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Federal Circuit Rejects District Court’s Action to Delist Patent from FDA’s Orange Book

October 12, 2001

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Last Month at the Federal Circuit - November 2001

Judges: Mayer (author), Newman, and Michel

In Mylan Pharmaceuticals, Inc. v. Thompson, No. 01-1257 (Fed. Cir. Oct. 12, 2001), the Federal Circuit reversed a district court’s grant of a preliminary injunction that had ordered Bristol-Myers Squibb (“BMS”) to delist a patent from the Orange Book, concluding that there is no private right of action to seek delisting.

BMS owns U.S. Patent No. 4,182,763 (“the ‘763 patent”), which claims a method of treating anxiety by administering buspirone hydrochloride, the active ingredient in BMS’s BuSpar®. Mylan Pharmaceuticals, Inc. (“Mylan”) had received tentative Food and Drug Administration (“FDA”) approval for its generic version of BuSpar® and had prepared to enter the market on November 21, 2000, the day that the ‘763 patent would expire. Approximately eleven hours before that expiration, BMS identified to the FDA a newly issued patent, U.S. Patent No. 6,150,365 (“the ‘365 patent”), for listing in the Orange Book. Upon receiving the ‘365 patent from BMS, the FDA listed it in the Orange Book and, as required by the statute, suspended approval of Mylan’s Abbreviated New Drug Application.

Mylan brought suit in the District Court for the District of Columbia for a DJ that BMS had improperly listed the ‘365 patent and sought a preliminary injunction requiring BMS to take steps to have it delisted from the Orange Book. The district court had determined that it had subject-matter jurisdiction, that Mylan was not attempting to enforce the Food, Drug, and Cosmetic Act (“FDCA” or “the Act”) against BMS, and that Mylan was entitled to a preliminary injunction ordering BMS to have the ‘365 patent delisted. BMS appealed to the Federal Circuit.

On appeal, BMS argued that Mylan had not asserted a cognizable cause of action, but rather was impermissibly attempting to enforce the FDCA against BMS. According to Bristol, declaratory relief was improper because, under the well-pleaded complaint rule for analyzing DJ suits, BMS would have had no action against Mylan to “list” the ‘365 patent.

Mylan insisted that the “mirror image” of its DJ suit was not a suit to list the patent, but rather was the expected patent infringement suit under 35 U.S.C. § 271(e)(2)(A) that BMS would likely bring. Mylan argued that had it filed a Paragraph IV certification for the ‘365 patent, BMS would have charged it with infringement. According to Mylan, one of the defenses available to it in response to that hypothetical suit would have been a counterclaim that the ‘365 patent was improperly listed in the Orange Book.

The Federal Circuit disagreed. First, the Court observed that delisting is not one of the recognized statutory or equitable defenses to charges of patent infringement. Moreover, the Federal Circuit determined that the Hatch-Waxman amendments to the Act did not create a new defense to patent infringement. Rather, the Court concluded, Mylan’s action was in essence an attempt to assert a private right of action for delisting under the Act. The FDCA, however, expressly prohibits private actions to enforce its provisions. Accordingly, Mylan’s request for a preliminary injunction to have the patent delisted should have been denied.