The court orders the removal of improper patent listings, clearing the path for lower-cost medications.
The Federal Circuit U.S. Court of Appeals recently upheld a lower court’s decision requiring Teva Pharmaceuticals to remove several asthma inhaler patents from the FDA’s Orange Book. The ruling follows a legal dispute with Amneal Pharmaceuticals, which sought FDA approval to produce a generic version of ProAir HFA, Teva’s branded asthma inhaler.
The Federal Trade Commission (FTC) supported the decision, emphasizing that these improperly listed patents delayed competition and hindered the availability of affordable generic drugs. The FTC had previously contested similar patent listings across various devices, including epinephrine autoinjectors and diabetes medications.
“We are pleased the court agreed with the FTC that these improper inhaler patent listings must be wiped from the Orange Book. Removal of junk patent listings is critical to ensuring drugmakers can fairly compete to offer generic drugs at a lower price for consumers,” Director Hannah Garden-Monheit of the FTC’s Office of Policy Planning, said in response to the appellate court’s decision ordering the delisting.
The Orange Book, maintained by the FDA, catalogs approved drug patents but can obstruct competition if misused. In 2023, the FTC issued a policy statement pledging to review improper patent submissions.
As the Lord Leads, Pray with Us…
- For members of the FTC as they seek to ensure competition in the pharmaceutical industry.
- For FDA officials as they maintain the Orange Book of drug patents.
- For judges of the circuit courts to rule with prudence on health and medical cases.
Sources: Federal Trade Commission
