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.
The purpose of the Hatch Waxman framework is to balance 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.View Full Point of Law
Issue. Is the FDA’s role regarding the accuracy of the Orange Book purely ministerial?
Held. (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.
Discussion. 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.