Mylan Pharmaceuticals, Inc. v. U.S. Food and Drug Administration case brief

Mylan Pharmaceuticals, Inc. v. U.S. Food and Drug Administration case brief summary
454 F.3d 270 (2006)

CASE SYNOPSIS

Defendant Food and Drug Administration (FDA) denied plaintiff pharmaceutical company's petition to prohibit the sale of authorized generics during the company's exclusivity period. The company filed an action under 5 U.S.C.S. § 706(2)(A), alleging that the denial was arbitrary and capricious. The United States District Court for the Northern District of West Virginia dismissed the complaint for failure to state a claim. The company appealed.

CASE FACTS
The FDA approved the company's application to sell a generic version of a drug that a patent holder sold under a brand name. Because the company was the first applicant to file an abbreviated new drug application (ANDA) under 21 U.S.C.S. § 355(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act (FFDCA), § 355(j)(5)(B)(iv) allowed the company to sell its drug without competition from later ANDA applicants for 180 days. Anticipating that the patent holder would grant a third party a license to sell an authorized generic version of the drug, the company filed a petition requesting that the FDA prohibit the sale of authorized generics during the exclusivity period. The FDA denied the petition, concluding that the FFDCA did not prohibit the patent holder's use of alternative marketing practices for its own approved drug.


DISCUSSION

• On appeal, the court held that the complaint was properly dismissed because the unambiguous language of § 355(j)(5)(B)(iv) did not grant the FDA the power to prohibit the marketing of authorized generics during the exclusivity period. 
• The company's position departed from the statute's language, and the FDA's action was not inconsistent with its prior position.

CONCLUSION
The court affirmed the district court's judgment.


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