Citation. aaiPharma Inc. v. Thompson, 296 F.3d 227, 63 U.S.P.Q.2D (BNA) 1670 (4th Cir. N.C. July 10, 2002)
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Brief Fact Summary.
AaiPharma (Plaintiff) wanted its patent included in the Orange Book as a patent related to the brand name drug Prozac.Â The patentee, as the NDA holder, refused to list Plaintiff’s patent and the FDA did not force it.Â Therefore, Plaintiff missed the notification required of ANDA applications because its patent was not listed in the Orange Book.
Synopsis of Rule of Law.
The FDA’s role regarding the accuracy of the Orange Book is purely ministerial.
Pioneer (i.e., brand name) drug manufacturers are required to submit a New Drug Application (NDA) to the FDA for approval.Â NDA applicants are required to provide the FDA a listing of all patents that claim the approved drug or method to use that drug.Â Once it approves the NDA, the FDA then publishes the list in the “Approved Drug Products with Therapeutic Equivalence Evaluations” also known as the “Orange Book.”Â The Hatch-Waxman Act created the opportunity for manufacturers of generic drugs to enter the market without spending a lot of money on clinical studies to demonstrate the generic drug’s safety and efficacy.Â The generic manufacturer is able to submit an Abbreviated New Drug Application (ANDA), which relies on clinical studies by the pioneer drug manufacturer.Â The NDA applicant must supplement its Orange Book list about new patents that issue while approval is pending or within 30 days of new patents issued after approval.Â An ANDA applicant reviews the Orange Book patents and makes one of four certifications with its ANDA:Â (I) no pioneer drug patent information submitted to FDA; (II) the patent has expired; (III) patent will expire on a certain date; or (IV) patent is invalid or will not be infringed.Â A paragraph IV certification requires notice to the patentee and the NDA holder, which triggers a 45-day review period in which the patentee could file suit for infringement.Â If suit is filed, the ANDA is automatically stayed for 30 months.Â If the patent is not listed in the Orange Book, the ANDA applicant is not required to file a paragraph IV certification.Â Plaintiff received a patent on a variant of the active drug in Prozac.Â It tried to have its patent included in the Orange Book because the patent of Eli Lilly & Co., the patentee of Prozac and the holder of the NDA, was about to expire and several generic manufacturers planned to launch generic versions immediately.Â By including the Plaintiff’s patent, generic manufacturers would be required to give notice to Plaintiff and trigger the review and potential stay periods.Â Only the NDA holders can submit patents for listing in the Orange Book, therefore Plaintiff asked Lilly to submit.Â The patentee refused and Plaintiff asked the FDA (Defendant) to intervene.Â Following procedure, the FDA requested Lilly confirm whether its Orange Book listing was correct.Â When Plaintiff did not get its patent listed, it sued Defendant under the Administrative Procedure Act hours before Defendant was to approve the generic manufacturer’s ANDAs.Â The district court denied relief and Plaintiff appealed.
Is the FDA’s role regarding the accuracy of the Orange Book purely ministerial?
(Michael, J.)Â If the Plaintiff claims Prozac, then Lilly is obligated to list the patent in the Orange Book.Â However, enforcement methods are no clear.Â According to precedent, a generic drug manufacturer cannot sue an NDA holder to delist a patent, so it follows that a third-party patentee cannot force an NDA holder to list a patent.Â Plaintiff therefore sued Defendant instead of Lilly.Â The FDA argues it plays a purely ministerial role in publishing the Orange Book with no responsibility to evaluate the accuracy of patent listings.Â Plaintiff states the Defendant, once notified of a failure to list a patent, must do more than request the NDA holder list the patent.Â The Chevron analysis applies here. The first step is whether Congress has addressed the controlling issue.Â Defendant and Plaintiff assert different provisions of 21 UY.S.C. Â§ 355 to support each position and this Court finds conflict between the provisions.Â Therefore, Congress failed to express its clear intent on whether Defendant is obligated to make sure the Orange Book is accurate.Â The next step is to determine if the Defendant’s construction is permissible.Â The construction is definitely reasonable, but might be undermined by the subsections (d)(6) and (e)(4).Â Subsection (d)(6) requires the Defendant refuse an NDA that does not include the patent information.Â Plaintiff interprets this to mean that the Defendant must evaluate the list to ensure accuracy.Â However, the more modest reading is that Defendant must reject the NDA if the list is omitted entirely.Â This is the better reading.Â Subsection (e)(4) requires Defendant to withdraw NDA approval if the NDA holder does not file the list of patents within thirty days of notice from Defendant that the list was omitted.Â Plaintiff argues this subsection gives Defendant permission to withdraw NDA approval if it notifies the NDA holder that a patent was omitted from the list and the holder refuses to amend.Â The better reading is that this allows NDA holders, granted approval prior to the passage of the Hatch-Waxman Act, thirty days from notice to file the list.Â Therefore, Defendant’s construction of Â§ 355 is permitted.
The FDA is not obligated to ensure the accuracy of the patent information listed in the Orange Book but can rely exclusively on the self-report of the NDA holder.Â That statute is written in mandatory terms, but there are no enforcement methods in place to ensure compliance.Â This oversight has not yet been addressed by Congress.