Mylan Laboratories, Inc. v. Thompson

Decision Date30 November 2004
Docket NumberNo. 04-5296.,04-5296.
Citation389 F.3d 1272
PartiesMYLAN LABORATORIES, INC., et al., Appellants, v. Tommy G. THOMPSON, Secretary, United States Department of Health and Human Services, et al., Appellees.
CourtU.S. Court of Appeals — District of Columbia Circuit

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

E. Anthony Figg argued the cause for the appellants. Thomas C. Goldstein was on brief.

Paul F. Brinkman, Amy S. Manning and Thomas J. Parker were on brief for amicus curiae Generic Pharmaceutical Association in support of appellants.

Howard S. Scher, Attorney, United States Department of Justice, argued the cause for the appellees. Peter D. Keisler, Assistant Attorney General, Kenneth L. Wainstein, United States Attorney, Douglas N. Letter, Counsel, United States Department of Justice, and Alex M. Azar, II, General Counsel, Daniel E. Troy, Chief Counsel, and Eric M. Blumberg, Deputy Chief Counsel, United States Department of Health & Human Services, were on brief for federal appellees. Andrew E. Clark and Karen E. Schifter, Attorneys, United States Department of Justice, entered appearances.

Anthony Herman, Peter O. Safir, Carolyn F. Corwin and Kelly M. Jaske were on brief for appellees Alza Corporation and Janssen Pharmaceutica, Inc.

Bruce N. Kuhlik, David E. Korn and Donald O. Beers were on brief for amicus curiae Pharmaceutical Research and Manufacturers of America in support of the appellees.

Gary W. Brown was on brief for amicus curiae Candlelighters Childhood Cancer Foundation National Office in support of the appellees.

Before: EDWARDS and HENDERSON, Circuit Judges, and WILLIAMS, Senior Circuit Judge.

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 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.

I.

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 thirty-month 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.1

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 exclusivity provision expressly addresses the effect of a grant of pediatric exclusivity, depending on the particular certification included in the ANDA:

(2)(A) if the drug is the subject of —

(i) a listed patent for which a certification has been submitted under [paragraph II] and for which pediatric studies were submitted prior to the expiration of the patent (including any patent extensions); or

(ii) a listed patent for which a certification has been submitted under [paragraph III],

the period during which an application may not be approved under ... section 355(j)(5)(B) of this title shall be extended by a period of six months after the date the patent expires (including any patent extensions); or

(B) if the drug is the subject of a listed patent for which a certification has been submitted under [paragraph IV], and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under ... section 355(j)(5)(B) of this title shall be extended by a period of six months after the date the patent expires (including any patent extensions).

21 U.S.C. § 355a(c)(2)(A)-(B).2

Finally, 35 U.S.C. § 271, a patent statute provision, authorizes the following remedies in a patent infringement action:

(4) For an act of infringement described in paragraph (2)

(A) the court shall order the effective date of any approval of the drug or veterinary biological product involved in the infringement to be a date which is not earlier than the date of the expiration of the patent which has been infringed,

(B) injunctive relief may be granted against an infringer to prevent the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug or veterinary biological product, and

(C) damages or other monetary relief may be awarded against an infringer only if there has been commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug or veterinary biological product.

The remedies prescribed by subparagraphs (A), (B), and (C) are the only remedies which may be granted by a court for an act of infringement described in paragraph (2), except that a court may award attorney fees under section 285.

35 U.S.C. § 271(e)(4).

B. This Proceeding

Appellee ALZA owned U.S. Patent No. 4,588,580 ('580 patent) for Duragesic. By its terms the '580 patent expired on July 23, 2004.

In July 1999 the FDA wrote ALZA requesting that it perform pediatric studies of Duragesic pursuant to 21 U.S.C. § 355a(c). ALZA submitted the requested studies in November 2002. On January 29, 2003 the FDA granted ALZA a six-month pediatric exclusivity period.

Meanwhile, in October 2001 Mylan filed with the FDA an ANDA to market its generic fentanyl transdermal system pursuant to 21 U.S.C. § 355(j) with a paragraph IV certification that ALZA's '580 patent was invalid or would not be infringed by Mylan's marketing of its generic product. As required under 21 U.S.C. § 355(j)(2)(B), on December 6, 2001 Mylan sent ALZA notice of its ANDA application and certification which ALZA received on December 10, 2001. On January 25, 2002, the...

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