Revisiting FDA’s Original Guidance on Orange Book Listability in Light of Heightened FTC Scrutiny
Friday, November 17, 2023
Orange Book Listability FDA Guidance

The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward.  Patents covering the approved drug product (active pharmaceutical ingredient) or its methods of use can be listed.  However, other kinds of patents may require a more careful evaluation, especially in light of a recent policy statement issued by the FTC signaling plans “to scrutinize improper Orange Book listings to determine whether these constitute unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act.” The FTC’s rationale is that improperly listed patents may prohibit competing products from entering the market and increasing competition.

In light of the FTC’s increased scrutiny of Orange Book listings, a renewed look at the FDA's original guidance on Orange Book listability provides some insight into the types of listings the FTC may be more likely to challenge and what companies can do to reduce that risk. For example, beyond the straightforward types of patents covering new drug compounds and methods of use, FDA guidance contained in the Federal Register Notice of June 18, 2003 containing the final listing rule (21 CFR 314) provides that patents covering “metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems” are potentially listable. The June 18, 2003 guidance also states that:

[t]he key factor is whether the patent being submitted claims the finished dosage form of the approved drug product. Patents must not be submitted for bottles or containers and other packaging, as these are not ‘‘dosage forms.’’

Various other categories of patents, including metabolites, product-by-process, and polymorph patents are also discussed in the FDA’s June 18, 2003 guidance. 

There are a number of lessons to be drawn from this guidance. When prosecuting patent applications relating to drug device combinations, it may be advantageous to pursue claims to the finished product(s) and claims that specifically recite the active ingredient(s) or drug class, as well as focusing on aspects of the device that may be integral to the approved drug product. When reviewing Orange Book listings for compliance with the guidance, greater scrutiny may be given to listed patents that do not recite the drug or otherwise relate to the finished product. In the special case of polymorph patents, the rule permits listing a polymorph patent that does not cover the approved product if the NDA holder certifies that there is data showing that the polymorph performs the same way as the approved product.

Additionally, stakeholders should be on the look-out for new guidance from FDA. The agency indicated in its Jan. 2022 Report to Congress under the Orange Book Transparency Act that FDA will create a multidisciplinary working group within the agency to “evaluate whether additional clarity is needed regarding the types of patents, patent information, or other patent-related information that should be included in, or removed from, the Orange Book.” The FDA has also issued a June 2020 request for comments from the public on Orange Book listing issues, which includes requesting comments on the listing of REMS-related patents and patents for digital applications.


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