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Mylan Labs., Inc. v. Thompson

United States Court of Appeals for the District of Columbia Circuit

November 8, 2004, Argued ; November 30, 2004, Decided

No. 04-5296


 [**442]  [*1274]   KAREN LECRAFT HENDERSON, Circuit Judge: Appellants Mylan Laboratories, Inc. Mylan Technologies, Inc. and Mylan Pharmaceuticals, Inc (Mylan) appeal the district court's summary judgment upholding the decision of appellee Food and Drug Administration (FDA). The FDA decision granted appellees ALZA Corp. and Janssen Pharmaceutica, Inc, both subsidiaries of Johnson and Johnson, (collectively, ALZA) a six-month period of pediatric marketing exclusivity, pursuant to 21 U.S.C. § 355a, following expiration of the final patent for ALZA's brand name transdermal fentanyl system, the Duragesic patch, which releases fentanyl, a narcotic analgesic, through the skin to treat chronic pain. Mylan contends the FDA's final approval of Mylan's Abbreviated New Drug Applications (ANDA) to market a generic version of the Duragesic patch, granted [***3]  before the FDA issued the decision challenged here, entitled Mylan to market its generic product immediately upon expiration of the patent pursuant to 21 U.S.C. § 355(j), without regard to pediatric exclusivity. For the reasons set out below, we affirm the district court's judgment upholding the FDA's decision.

This appeal requires that the court consider three separate statutory provisions: (1) 21 U.S.C. § 355(j), a provision of the 1984 Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA), which authorizes a drug manufacturer [**443]   [*1275]  to submit an ANDA to the FDA to obtain approval of a generic version of a previously approved drug; (2) 21 U.S.C. § 355a, a 1997 amendment to the FDCA, which authorizes an extra six-month "pediatric exclusivity" period following expiration of a drug patent for a patent holder that has satisfactorily conducted pediatric testing of its drug upon the FDA's request; and (3) 35 U.S.C. § 271(e)(4), a patent statute, also enacted in the Hatch-Waxman Amendments, which sets out the exclusive remedies available in a patent infringement action.  [***4]  We begin with a summary of these three provisions.

A. Applicable Statutory Provisions

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389 F.3d 1272 *; 363 U.S. App. D.C. 440 **; 2004 U.S. App. LEXIS 24675 ***


Prior History:  [***1]  Appeal from the United States District Court for the District of Columbia. (No. 04cv01049).

Mylan Labs., Inc. v. Thompson, 332 F. Supp. 2d 106, 2004 U.S. Dist. LEXIS 16103 (D.D.C., 2004)

Disposition: Affirmed.


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