“FDA’s continued silence on this issue is untenable, and patients ultimately stand to benefit through clarity on these requirements.” – Senator Bill Cassidy
On Monday, September 30, U.S. Senator Bill Cassidy (R-LA), Ranking Member of the Senate Committee on Health, Education, Labor, and Pensions, sent a letter to Robert Califf, Commissioner of the Food & Drug Administration (FDA), urging the agency to issue guidelines clarifying requirements for listing patents covering FDA-approved drugs in the agency’s Orange Book. Cassidy’s letter criticizes the FDA’s inaction in response to industry pleas for clarity, calling for quick action to address confusion created by the Federal Trade Commission’s (FTC) recent enforcement campaign against allegedly improper Orange Book patent listings.
Drug companies obtaining FDA approval to market their branded drugs are required by the Hatch-Waxman Act to list patents covering the drug and associated methods of use in the FDA’s Orange Book. For companies manufacturing drug delivery products like inhalers and auto-injectors, questions as to whether device patents should be included in the Orange Book listings for approved drugs have long existed. As far back as 2005, major drugmaker GlaxoSmithKline requested an advisory opinion on the subject from the FDA, seeking guidance regarding delivery device patents that don’t specifically claim the approved drug’s active ingredients.
Lack of Clarity from FDA Created Vacuum Leading to FTC Enforcement Campaign
The FDA denied requests for advisory opinions from GlaxoSmithKline and others, opting instead to issue a request for comments in June 2020 seeking input on patent listing requirements for drug-device combination products. While prescribing regulations for Orange Book listings is the responsibility of the FDA, its absence on the device patent issue has allowed the FTC to step into the vacuum. Last November, the FTC notified a series of 10 drug companies that the agency was challenging certain patent listings in the Orange Book, including several covering drug delivery devices, as unfair methods of competition prohibited by Section 5 of the FTC Act.
The FTC has opined in amicus briefing that device patents that do not claim the drug compound should be delisted from the Orange Book, a stance that has created confusion for drugmakers. Cassidy’s letter notes that achieving the right balance on the proper scope of Orange Book listings is critical for drug developers and generic drugmakers alike. Failing to list patents covering an approved drug and associated methods of use prevents generic companies from obtaining the benefits of first-filer exclusivity under the Hatch-Waxman Act, which gives generic drugmakers 180 days of market exclusivity for filing the first challenge to Orange Book-listed patents.
The FDA’s inaction on clarifying drug delivery device patent requirements has been underscored by government reports produced pursuant to the Orange Book Transparency Act of 2020, which includes provisions first drafted by Cassidy. This bill directed the Government Accountability Office (GAO) to produce a study on industry stakeholder views of Orange Book listing requirements, which reflected widespread belief that the FDA’s guidance on device patents has been insufficient. By contrast, the FDA’s own report on Orange Book patent listings “rehashed the points made in comments submitted on this issue, without taking any further position,” according to Cassidy. The letter explained:
“FDA is like a referee hiding the rulebook from athletes, then egging on a referee from another sport to enforce it. FDA’s continued silence on this issue is untenable, and patients ultimately stand to benefit through clarity on these requirements.”
Cassidy’s letter concludes with a series of questions for the FDA that seek information on the agency’s views of the pros and cons of listing device patents in the Orange Book, and an explanation as to why the FDA has not acted to clarify this requirement for industry stakeholders. Cassidy is also seeking information on the status of a multidisciplinary working group announced by the FDA in its January 2022 report on Orange Book listings, and any instances where Hatch-Waxman stays or generic drug approvals have hinged solely on a device patent listing. Cassidy has requested the FDA to respond to these questions fully by October 25 of this year.
