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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

Opinion

 [**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 ***

MYLAN LABORATORIES, INC., ET AL., APPELLANTS v. TOMMY G. THOMPSON, SECRETARY, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, ET AL., APPELLEES

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.

CORE TERMS

patent, certification, infringement, pediatric, expiration, effective date, district court, generic, expiration date, final approval, patent holder, notice, regulation, effective, tentative, fentanyl, studies, window, deference, six-month, delayed, invalid, amend, statutory provisions, patent infringement, circumstances, transdermal, effect immediately, approved drug, new drug

Business & Corporate Compliance, Governments, Agriculture & Food, Federal Food, Drug & Cosmetic Act, Infringement Actions, Defenses, Experimental Use & Testing, Civil Procedure, Judgments, Entry of Judgments, Consent Decrees, Infringing Acts, Making & Manufacturing Infringement, Patent Law, Jurisdiction & Review, Subject Matter Jurisdiction, Appeals, General Overview, Appeals, Standards of Review, De Novo Review, Summary Judgment Review, Standards of Review, Administrative Law, Judicial Review, Abuse of Discretion, Environmental Law, Administrative Proceedings & Litigation, Judicial Review, Arbitrary & Capricious Standard of Review, Deference to Agency Statutory Interpretation, Agency Rulemaking, Informal Rulemaking