Mylan Pharmaceuticals, Inc. v. Thompson case brief

Mylan Pharmaceuticals, Inc. v. Thompson case brief summary
268 F.3d 1323 (2001)

CASE SYNOPSIS

Defendant appealed from an order of United States District Court for the District of Columbia granting plaintiff's motion for a preliminary injunction directing defendant to take measures to delist its U.S. Patent No. 6,150,365 ( '365 patent) from the Food and Drug Administration's (FDA) "Orange Book" and directing the FDA to grant final approval to plaintiff's Abbreviated New Drug Application (ANDA).

CASE FACTS
The district court held that plaintiff was entitled to declaratory relief that the '365 patent was improperly listed in the Orange Book under the patent laws and the Declaratory Judgment Act, as a defense to the infringement suit defendant could have brought under 35 U.S.C.S. § 271(e)(2). The district court found that the '365 patent did not claim the drug for which the plaintiff submitted its ANDA or claim a method of using such drug upon which a claim of patent infringement could reasonably be asserted.

ARGUMENT
Defendant argued that granting declaratory relief was improper because, under the well-pleaded complaint rule, it would have no cause of action against plaintiff to "list" the '365 patent.


DISCUSSION

• The court of appeals found that neither the general patent laws nor the Hatch-Waxman Amendments, 35 U.S.C.S. §§ 156,271, and 282, permitted plaintiff's asserted action for declaratory relief. 
• The court reasoned that plaintiff's action against defendant was in essence an attempt to assert a prohibited private right of action for "delisting" under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.S. § 355 (j)(5)(B)(iii)(III).

CONCLUSION
The district court's judgment was reversed where plaintiff, abbreviated new drug applicant's, asserted action for declaratory relief was in essence an attempt to assert a prohibited private right of action for "delisting" under the Federal Food, Drug, and Cosmetic Act.

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