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Mylan Laboratories, Inc. v. Thompson

November 30, 2004


Appeal from the United States District Court for the District of Columbia (No. 04cv01049)

Before: Edwards and Henderson, Circuit Judges, and Williams, Senior Circuit Judge.

The opinion of the court was delivered by: Karen Lecraft Henderson, Circuit Judge

Argued November 8, 2004

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 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 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. We begin with a summary of these three provisions.

A. Applicable Statutory Provisions

The ANDA provision, 21 U.S.C. § 355(j), creates an approval short-cut for applicants seeking to market generic versions of approved drugs. Under this provision the generic applicant need not conduct its own clinical trials if the ANDA certifies that the generic version is bioequivalent to an approved drug. In addition, the ANDA must include one of four statutory "certifications" regarding the approved drug's patent status:

(I) that such patent information has not been filed,

(II) that such patent has expired,

(III) ... the date on which such patent will expire, or

(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted; ....

21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV) (paragraphs I-IV). If the ANDA contains a paragraph IV certification, the applicant must, within 20 days of the ANDA filing, send a notice to the patent holder stating it has submitted an ANDA with the paragraph IV certification and setting out the factual and legal bases for believing the patent is invalid or will not be infringed. 21 U.S.C. § 355(j)(2)(B).

The ANDA provision also establishes the effective date for approval of the ANDA, depending on the particular certification made.

If the applicant makes a certification under paragraph I or II, "the approval may be made effective immediately." 21 U.S.C. § 355(j)(5)(B)(i).

If the certification is under paragraph III, "the approval may be made effective on the date certified under [paragraph III]." 21 U.S.C. § 355(j)(5)(B)(ii).

If the certification is under paragraph IV, "the approval shall be made effective immediately" unless the patent holder files an infringement action in the district court within 45 days of receiving the notice, in which event "the approval shall be made effective upon the expiration of the thirtymonth period beginning on the date of the receipt of the notice," unless the district court rules on the infringement claim within the 30-month period. See 21 U.S.C. § 355(j)(5)(B)(iii). If the district court issues a ruling during the 30-month stay period, the ANDA approval date is determined by the decision of the district court, or the appellate court if appealed.*fn1

The pediatric exclusivity provision, 21 U.S.C. § 355a, provides an incentive for a drug patent holder to conduct pediatric studies of a drug which the FDA believes may have beneficial pediatric use. Under the statute, the FDA must first request that the drug patent holder conduct pediatric studies; if the requested studies are satisfactorily completed and submitted within the FDA-prescribed time frame, the patent holder is eligible to receive a six-month period of market exclusivity for the drug beyond the patent expiration date. 21 U.S.C. § 355a(c). The pediatric ...

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