Aaipharma Incorporated v. Thompson

296 F.3d 227 (2002)

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Nature of the Case

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Facts

Hatch-Waxman amended both the FFDCA and the patent laws in an effort to strike a balance between 'two conflicting policy objectives: to induce name-brand pharmaceutical firms to make the investments necessary to research and develop new drug products, while simultaneously enabling competitors to bring cheaper, generic copies of those drugs to market.' Hatch-Waxman created a streamlined procedure for FDA approval of generic drugs. A drug company that wishes to market a generic version of a brand name drug may now submit an Abbreviated New Drug Application (ANDA) to the FDA. The generic manufacturer can rely on the clinical studies performed by the pioneer drug manufacturer and is not required to prove the safety and effectiveness of its generic drug from scratch. The generic manufacturer must prove only that its drug is bioequivalent to the brand name drug it wants to copy. Also, a generic drug manufacturer no longer infringes the patents on a brand name drug by performing acts necessary to prepare an ANDA. The Act requires each drug company filing an NDA to include in its application a list of all the patents that 'claim the drug for which the applicant submitted the application or which claim a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.' §355(b)(1). If the FDA approves the application, the agency is required to publish this list in the Orange Book. An NDA applicant must also amend its application to include information about any new patents claiming its drug that issue while the NDA is pending. The holder of an approved NDA is required to submit to the FDA for Orange Book listing any new patents that claim the approved drug within thirty days of their issuance. §355(c)(2). An ANDA applicant seeking to copy that drug must make one of the following four certifications in its initial application for FDA approval: (I) that no patent information for the pioneer drug has been submitted to the FDA (a 'paragraph I certification'), (II) that the patent has expired (a 'paragraph II certification'), (III) that the patent will expire on a specific date (a 'paragraph III certification'), or (IV) that the patent 'is invalid or will not be infringed by the manufacture, use, or sale of the new drug' for which the ANDA applicant seeks approval (a 'paragraph IV certification'). §355(j)(2)(A)(vii)(I)-(IV). An ANDA applicant must also make an additional certification as to any new patent listed in the Orange Book while its application is pending, so long as the NDA holder submits the new patent to the FDA for listing no more than thirty days after the patent's issuance. The certification made by the ANDA applicant determines the date on which FDA approval of the application can become effective. ANDAs containing paragraph I or II certifications may be approved immediately if the FDA finds that all the relevant scientific and regulatory requirements have been met. A paragraph III certification becomes effective on the patent's expiration date, assuming that other FDA requirements have been satisfied. A paragraph IV certification indicates an intent to market a product before the relevant patents have expired. A paragraph IV certification requires the ANDA to give notice of this certification to both the NDA holder and the patent holder and must explain in detail why it believes that the patent is invalid or will not be infringed by the generic drug for which it seeks approval. Hatch-Waxman provides that a paragraph IV certification creates a cause of action for patent infringement in the patent holder. §271(e)(2)(A). After notice of the certification, the patent holder has forty-five days in which to file a suit for patent infringement. Failure to file means that the FDA may approve the ANDA without delay. Filing automatically stays the ANDA for up to thirty months. P received the '853 patent on a polymorphic variant of the active ingredient in Prozac a drug manufactured by Lilly. Lilly's claim of exclusivity for Prozac under the patent laws was scheduled to expire on August 2, 2001. Generic drug manufacturers were set to begin marketing generic versions of Prozac the next day. P sought to have its '853 patent included in the Orange Book listing for Prozac. Lilly refused to submit the '853 patent to the FDA. P sent a letter to D telling D it had an obligation to intervene. D refused to become an arbiter of the correctness of Orange Book listings. P sued D hours before D was set to approve the marketing of several generic versions of Prozac stating that D's failure to require Lilly to list the '853 patent in the Orange Book was 'arbitrary, capricious . . . or otherwise not in accordance with law' under §706(2)(A) of the APA and asked the court to order the D to require Lilly to submit the '853 patent for listing in the Orange Book. The district court denied the motion for preliminary relief from the bench. It held that Hatch-Waxman places the responsibility for deciding which patents to list in the Orange Book solely on NDA holders. D's task was simply is to publish -- without question -- whatever patent information . . . is supplied to it by the NDA holder pursuant to the statute. P appealed.