Citations
- 389 F.3d 1272
Full opinion text
Opinion for the court filed by Circuit Judge HENDERSON.
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 Jans-sen 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 trans-dermal 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©, without regard to pediatric exclusivity. For the reasons set out below, we affirm the district court’s judgment upholding the FDA’s decision.
I.
This appeal requires that the court consider three separate statutory provisions: (1) 21 U.S.C. § 355©, 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. § 355Q), 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 bioe-quivalent 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; ....