FTC investigates Teva over refusal to remove improperly listed patents from Orange Book
FTC investigates Teva over refusal to remove improperly listed patents from Orange Book
Published: Jul 02, 2024
By Tristan Manalac
BioSpace
The Federal Trade Commission has launched a probe into Teva Pharmaceuticals over the company’s alleged refusal to remove questionable patents listed in the FDA’s Orange Book, according to The Washington Post.
Citing confidential agency documents, The Washington Post revealed that the Federal Trade Commission (FTC) has slapped Teva with a civil investigative demand, which forces the company to hand over several documents—including financial data, analyses and internal communications—related to several contentious patents listed in the Orange Book.
Teva has until July 24 to comply with the FTC’s demands.
The FTC’s investigation of Teva represents an escalation of its recent campaign against patents it claims are “improperly or inaccurately” listed on the FDA’s registry. In October 2023, the FTC released a policy statement warning companies that it intended on “taking actions against companies and individuals that improperly list patents in the Orange Book.”
In November 2023, the FTC announced that it was challenging more than 100 patents from 10 drugmakers, including GSK, AbbVie and AstraZeneca. The FTC’s initial round of disputes focused on drug-device products such as inhalers, epinephrine injectors and multidose bottles.
At the time, FTC Chair Lina Khan said in a statement that these improperly listed patents “can significantly drive up the prices Americans must pay for medicines and drug prices,” while also compromising “fair and honest competition” across the market.
In December 2023, three companies—Impax, Kaléo and GSK—put in requests to delist some of their patents in contention. GSK pulled several patents related to its asthma inhalers Arnuity Ellipta, Advair HFA, Ventolin HFA and Flovent HFA. Still, the pharma stood behind itsArnuity Ellipta patents, maintaining that the listing on the Orange Book was proper.
The FTC in April 2024 targeted Teva and its subsidiaries flagging patents for the companies’ asthma and chronic obstructive pulmonary disease inhalers. At the time, the FTC gave Teva 30 days to “withdraw or amend” its listing or insist, “under penalty of perjury,” that their patient listings are appropriate and comply with the FDA’s statutes.
The April 2024 disputes also included Novo Nordisk patents that protect its blockbuster GLP-1 therapy Ozempic (semaglutide).
Source: BioSpace
