The Federal Trade Commission on Tuesday offered up support for a proposed rule from the US Patent and Trademark Office that could help regulators more closely track pharma patent settlements that might be anticompetitive.
Under the PTO’s proposal, released in April, pharma and other companies would have to disclose all settlements that are not currently required to be disclosed but which the FTC says may pose antitrust risks.
“The proposed rule change would support the FTC’s ability to identify and investigate potentially unlawful settlements in the pharmaceutical sector and across other industries,” the FTC said in a statement.
Specifically, the commission points to detecting reverse payment settlements between brand-name and generic pharma companies, which can prevent lower-cost generics from coming to market.
Currently, companies are only required to disclose settlements if a dispute settles after a Patent Trial and Appeal Board trial. It’s a system, according to the FTC, that “encourages settlements prior to the institution of proceedings for those looking to avoid the consequences of disclosure.”
The new plan would help the FTC to monitor the situation more closely.
“Extension of disclosure requirements to any settlement regardless of timing or effective date would support the FTC’s ability to identify and investigate potentially unlawful settlements in the pharmaceutical context and more broadly,” the FTC said in its comment.
But PhRMA said in a comment it’s submitting later on Tuesday that these settlement agreements need to be taken care of separately from the PTO rulemaking.
Megan Van Etten, senior director of public affairs at PhRMA, told Endpoints News in an emailed statement, “PhRMA strongly suggests that the USPTO address settlement agreements through a separate rulemaking process that adequately considers how best to manage the confidentiality concerns around sensitive business information included in these settlement agreements that could harm the parties if made public.”
Under President Joe Biden’s FTC Director Lina Khan, the commission has touted the myriad ways in which it’s brought pressure on what it sees as anticompetitive practices in the pharma industry.
In April, the FTC also expanded its push to target improper pharma patents in the FDA’s Orange Book, while noting that its amicus brief from March was extensively cited in a district court decision ordering Teva to delist five patent listings. Last February, the FTC also pledged its support to use “march-in” rights to crack down on drug prices.