On September 14, 2023, the US Federal Trade Commission (FTC) issued a policy statement on “Brand Pharmaceutical Manufacturers’ Improper Listing of Patents” (the Policy Statement) in the US Food and Drug Administration’s (FDA’s) Orange Book.1 The FTC announced that it would carefully scrutinize brand drug manufacturers’ patent listing practices and consider enforcement action against any improper patent listings. The FDA voiced its support for the FTC’s efforts in the press release announcing the policy statement.2
The FDA’s support is notable, as it is the agency responsible for interpreting the patent listing provisions of the Food, Drug, and Cosmetic Act (FDCA). Despite repeated industry requests dating back nearly 20 years, the FDA has not provided sufficient clarity around its patent listing standards. The new FTC Policy Statement may make the consequences of that ambiguity more acute.
In light of the Policy Statement, brand drug manufacturers should carefully evaluate their patent listing decisions, both for pending products and for approved products for which patents are already listed in the Orange Book. Close collaboration between FDA regulatory counsel and patent counsel has always been important to ensure compliance with the FDA’s patent listing requirements, while preserving lawful patent protection. Given the FTC’s recent statements, it may now be critical to involve antitrust counsel, particularly where a listed patent may impact the approval timing of a generic competitor.
The FTC Policy Statement
The Policy Statement was issued to put brand drug manufacturers on notice that the FTC “intends to scrutinize improper Orange Book listings to determine whether these constitute unfair methods of competition” as a so-called “standalone” Section 5 violation.3 The FTC has signaled its increased willingness to bring such Section 5 cases in recent years.4
In addition, the FTC stated that it may consider enforcement action against brand drug manufacturers under a monopolization theory and scrutinize a brand drug manufacturer’s patent listing history during merger review.5 Finally, the FTC announced that it may begin disputing allegedly improper patent listings under FDA’s administrative patent listing dispute process.6
Two critical aspects of the FTC Policy Statement that brand drug manufacturers must consider:
- The FTC has raised the stakes by indicating that the individuals responsible for improper Orange Book listings can be held individually liable, and that the FTC may refer potential criminal violations to the Department of Justice;
- The FTC noted that its policy was not just forward-looking, but also retroactive. “Failure to remove” patents that are allegedly improperly listed “could result in legal liability,” according to the FTC’s statement.7
FDA’s Orange Book Listing Requirements and Potential Impact on Generic Applications
Brand drug manufacturers have long been required to submit certain patent information to FDA as part of their new drug applications (NDAs). Specifically, an NDA holder must submit information to FDA for:
each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that –
(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
(II) claims a method of using such drug for which approval is sought or has been granted in the application.8
FDA famously takes a “ministerial” approach to the patent listing process, not substantively evaluating the patent information provided by the NDA holder or the patents themselves. Instead, FDA publishes the submitted information in FDA’s publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the “Orange Book.” The Orange Book thus includes information on each patent submitted by the NDA holder, including whether the patent claims the drug substance, drug product and/or a method of use. For method of use patents, the Orange Book also lists the Use Code(s) provided by the NDA holder.9
As the FTC Policy Statement makes clear, the listing of patents in the Orange Book provides notice to generic manufacturers and other competitors who intend to seek approval in reliance on data contained in the brand drug manufacturer’s NDA. In exchange for this reliance, the approval of a generic drug manufacturer’s abbreviated new drug application (ANDA) is subject to regulatory exclusivity and patents listed with the brand manufacturer’s NDA. Accordingly, a generic applicant must include in its application a certification to each of the patents listed in the Orange Book with the brand drug.
If an ANDA applicant includes a “Paragraph IV certification” challenging the listed patent(s) as invalid or not infringed, the FDCA provides for a 30-month regulatory stay on the FDA’s authority to approve the ANDA application.10 This stay is designed to allow for the patent litigation to be resolved in federal district court, and may be terminated early if the litigation is resolved in the ANDA applicant’s favor. Thus, as the FTC points out in its statement, a patent that should not be listed in the Orange Book could lead to unnecessary delay in the FDA approval of a generic drug application.
FDA’s Silence Leads to Uncertainty Surrounding Listing Standards for Certain Patents
The issuance of the FTC Policy Statement underscores the consequences of the FDA’s reluctance to provide additional clarity around its patent listing regulations. In particular, the FDA has long declined to articulate clear standards around the listing of certain patents claiming a device component of a drug-device combination product. For years, brand drug manufacturers have sought more guidance from the FDA, including by submitting multiple requests for advisory opinions between 2005 and 2012.11 The FDA has not substantively responded to these requests. In recent years, similar questions have arisen with regard to the eligibility for listing of patents claiming elements of a brand drug product’s Risk Evaluation and Mitigation Strategy (REMS).
In 2020, the FDA opened a public docket seeking stakeholder input on Orange Book patent listing standards for device and REMS patents, as well as patents claiming methods of use and/or digital applications.12 Despite a high level of engagement and input from both brand and generic drug manufacturers, the FDA has not taken any steps to further articulate the standards for patent listing.
These developments put brand drug manufacturers in a difficult situation. Patent listing typically occurs at the time of a brand drug product’s approval, several years before the initiation of patent litigation and the opportunity for claim construction. As a result, patent listing decisions often require a fair amount of judgment to ensure regulatory compliance and to minimize enforcement risk.
In conclusion, brand drug manufacturers will find themselves under increased scrutiny. Careful evaluation of patent listing decisions is critical, and NDA holders should also consider reviewing their existing patent listings to assess any potential enforcement risk.
1 Federal Trade Commission Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book (“Policy Statement”) (Sept. 14, 2023), available at ftc.gov/system/files/ftc_gov/pdf/p239900orangebookpolicystatement092023.pdf.
4 See Federal Trade Commission Policy Statement Regarding the Scope of Unfair Methods of Competition Under Section 5 of the Federal Trade Commission Act (Nov. 10, 2022), available at https://www.ftc.gov/system/files/ftc_gov/pdf/P221202Section5PolicyStatement.pdf.
11 See Docket Nos. FDA-2005-A-0476 (Jan. 10, 2005) (submitted by GlaxoSmithKline), FDA-2006-A-0063 (Aug. 10, 2006) (submitted on behalf of AstraZeneca), FDA-2007-A-0099 (June 21, 2007) (also submitted on behalf of AstraZeneca) , FDA-2011-A-0363 (May 12, 2011) (submitted on behalf of Forest Laboratories), and FDA-2012-A-1169 (Nov. 27, 2012) (submitted on behalf of Novo Nordisk Inc.).