FTC eyes crackdown on improper drug patents in FDA's Orange Book

After a clutch of lawmakers last month challenged “sham patents” registered with the FDA’s Orange Book—the registry for patents of approved drugs—the Federal Trade Commission (FTC) is getting in on the action.

In a tentative agenda set for Sept. 14, the FTC said it will consider whether to adopt a policy statement "concerning the improper listing of patents" in the FDA's Orange Book. 

The FTC said the statement will discuss whether improper patents can "increase the cost of and reduce access to essential prescription drugs, imposing costs on individuals and society alike."

The agency will also consider whether listing sham patents in the Orange Book "may constitute an unfair method of competition," the FTC said.

The move comes soon after Rep. Pramila Jayapal, D-Washington, and Sen. Elizabeth Warren, D-Massachusetts, asked (PDF) the FDA to address “sham patents” that biopharma companies used to “hold off generic competition for at least 2.5 years, regardless of the outcome of any policy statement.”

The lawmakers urged the FDA to clarify guidelines for patents that can be listed in the regulator’s Orange Book.

Meanwhile, the FTC was recently embroiled in a lawsuit around Amgen's proposed takeover of Horizon Therapeutics. After angling to block the case, the FTC late last month suspended internal legal proceedings in a bid to reach “the proper resolution of this matter.”

At the start of September, the FTC said it reached a proposed consent order with Amgen to address the "potential competitive harm” that could result from the merger deal. Alongside the FTC, attorneys general from six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—moved to dismiss their injunction requests.

The FTC has been aware of problems with the patent system for some time. Way back in 2002, the FTC announced its “first complaint” against a pharmaceutical manufacturer, in which it accused Biovail Corporation of unlawfully acquiring an exclusive patent license to protect its “monopoly” on the market for GSK’s blood pressure and chest pain drug Tiazac and its generics.

More recently, the FTC filed a brief in support of Avadel CNS Pharmaceuticals’ position that Jazz Pharmaceuticals allegedly violated Orange Book standards. Specifically, in November 2022, the FTC took issue with a Jazz patent that covers a system for distributing the company's twice-nightly narcolepsy drug Xyrem under an FDA-required program to curb treatment-related risks.

The agency said Jazz's patent doesn't qualify for listing in the FDA's Orange Book. Once a patent is listed in the book, the FDA can't approve potential rivals for 30 months. 

Editor's Note: This story has been updated to specify that that the FTC did not sue Jazz Pharmaceuticals.