Revisiting FDA’s Original Guidance on Orange Book Listability in Light of Heightened FTC Scrutiny

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.

Disclaimer

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.