FDA’s Orange Book Listing Process: FTC Formally Joins the Fray

Morgan Lewis - As Prescribed

The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify potential violations of Section 5 of the FTC Act, which prohibits, among other things, unfair methods of competition.

The FTC’s policy statement suggests that the FTC views “improper” Orange Book listings as effectively per se violations of the FTC Act and will be actively enforcing its authority with regard to such listings.

The FTC has in the past brought enforcement actions and has more recently filed amicus briefs in private lawsuits supporting the contention that allegedly improper Orange Book listings may violate the antitrust laws by delaying competition from generic competitors; but the agency has not previously sought to scrutinize Orange Book listings generally to identify “improper” listings. It will do so now, according to the new policy statement.


The Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act), along with related patent and exclusivity information. The Orange Book plays a central role in the Hatch-Waxman framework of the FD&C Act, which governs the duration of market exclusivity of small molecule innovator drugs and restricts FDA approval of generic copies under Abbreviated New Drug Applications (ANDAs) and substantially similar drugs under 505(b)(2) applications.

Specifically, the Hatch-Waxman framework provides that (1) holders of New Drug Applications (NDAs) submit certain patent information pertaining to the product that is the subject of the NDA; (2) the FDA regularly update the Orange Book to include new information relating to these patents (e.g., if new patents are obtained for the product); and (3) ANDA and 505(b)(2) applicants referencing that NDA in their applications (because they propose to make the same or a similar drug) must make one of several certifications as to relevant listed patents, including that the generic or 505(b)(2) drug does not infringe the listed patents or the listed patents are invalid.

The submission of such a certification constitutes an act of artificial patent infringement permitting patent litigation to commence immediately. This scenario may also trigger an automatic, 30-month stay of approval by the FDA of the relevant ANDA or 505(b)(2) application, a period designed to allow patent litigation to play out prior to approval and subsequent marketing of the follow-on product. In other words, whether a patent is listed in the Orange Book determines whether patent litigation processes contemplated by the Hatch-Waxman framework applies.

Historically, the FDA has taken a “ministerial” approach to the validity or applicability of Orange Book patent listings and certifications and has stated that it has neither the expertise nor resources to address patent-related issues. Nonetheless, these listings and certifications, among other things, play a part in determining when the ANDA or 505(b)(2) application can be approved by the FDA and the timing of such approval (and hence the timing of market entry by the ANDA or 505(b)(2) applicant). Although the FD&C Act outlines which patents are to be listed in the Orange Book, there are nuances associated with determining whether a specific patent should be listed for an innovator drug or combination product. The FDA guidance on many of these nuances has been lacking, sometimes resulting in judicial resolution of the issue as part of Hatch-Waxman litigation.

In addition to reviewing Orange Book listings as noted above, the FTC notes that it may also consider a company’s history and practices around listing patents in the Orange Book during merger review and also notes the potential for individual criminal liability for making a false statement in its submission. It is likely it will also rely on market information from competitors, as well as other market intelligence.

The Policy and Questions that Remain

In light of this, sponsors of NDAs should carefully consider the contours of their Orange Book listing practices going forward as well as reviewing existing patent listings in the Orange Book. Because the FTC’s newly announced policy will focus on patents “improperly” listed in the Orange Book, it is critical for the FDA or FTC to provide more specific guidance on the proper scope of listed patents. Unfortunately, however, despite repeated requests from industry stakeholders, questions remain unanswered and further clarity on this will be necessary to enable compliance.

In the FTC’s statement, FDA Commissioner Robert Califf is quoted in support of the policy statement, noting that the FDA “stands ready to assist the FTC” with the policy. It is not clear what role, if any, the FDA will play here and if that role will continue to be only “ministerial” or if the FDA will provide evaluations of the clinical significance or timing of product improvements that are the subject of supplemental Orange Book listings to assist the FTC. With the announcement of this policy in particular, responses on these questions may be overdue.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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