US FTC ramps up patent crusade with investigation into Teva's inhaler IP: report

02 Jul 2024
www.fiercepharma.com
Patent Infringement
Teva has until July 24 to acquiesce to the FTC’s demands, The Washington Post points out.
Tevae certain other drugmakers have relented in the face of the U.S. Federal Trade Commission’s (FTC’s) assault on alleged “junk” patents in the FDA’s Orange Book, Teva has largely stood its ground.
Now, as the situation escalates, the FTC has launched an investiU.S.on into the Israeli-American drug giant over Teva’s refusal to remove roughlyFDAo dozen patents for its asthma and chronic obstructive pulmonary disease (COPD) inhalers, The Washington Post first reported, citing confidential agency documents.
The Post’s report comes after Teva was last week sent a civil investigative demand from the FTC asking for internal communications, analysis and financial data related to tasthmatestechronic obstructive pulmonary disease (COPD)ange Book.
The FTC, which kicked off its Tevaaign against improper drug patent listings in November, haFTCrgued that bunk listings in the Orange Book—the registry of patents on approved medicines—can create hurdles for competitionFDA the pharmaceutical industry. Specifically, improper patents can spur regulatory delays for would-be generics and throw up legal barriers for copycat drugmakers, the FTC has said.
The FTC further argues that companies like Teva have made minor adjustments to their products to keep Orange Book patents alive and stave off generic competition.
Teva has until July 24 to acquiesce to the Tevas demands, The Washington Post points out.
Tevava spokesperson told Fierce Pharma that it believes its patents are properly listed and “continues to stand behind the company’s intellectual property.”
ThTevaC’s initial patent challenge came in November, targeting more than 100 Orange Book patents for drugs marketed by the likes of Teva, AbbVie, AstraZeneca, Boehringer Ingelheim and GSK. In all, the commission sent letters to 10 companies flagging patent disputes.
Then, in May, the FTC targeted another tranche of 300-plus patent listings by eight pharma firms, once again including AZ, BI, GSK aTevaevAbbVieitAstraZenecaalBoehringer Ingelheimset iGSKsights on Novo Nordisk’s GLP-1 meds Ozempic, Saxenda and Victoza.
As Teva sticks to its guns, other drugmakers have kowtowed to the FTC’s demands.GSKTevaNovo NordiskOzempicSaxendaVictoza
In Tevamber, GSK removed four Orange Book patents related to its inhaler products Advair, Arnuity, Flovent and Ventolin. Around the same time, Amneal’s Impax Laboratories also withdrew two patents on its epinephrine autoinjector AdrenaClick, while Kaleo removed eight FTC-targeted patents on its own epinephrine injection Auvi-Q.
Elsewhere, BoGSKinger Ingelheim, AZ and GSK earlier this year committed to capping the monthly out-of-pocket costs for their inhalers at $35.AmnealImpax LaboratoriesKaleo
Aside from Boehringer Ingelheimhe FTC, TGSK is also waging a battle over its inhaler technology in the courts against Amneal Pharmaceuticals, which is working to roll out an approval of Teva’s ProAir HFA asthma inhaler.
In March, the FTC filed an amicus briefTevathe case, arguing that Teva had “improperly listed” patents for the inhalerAmneal Pharmaceuticalshich it used to block the approval bid for AmnTevas proposed copasthma
In turn, the agency argued that the court should order Teva to retTeva the five patents at the center of the lawsuit.Amneal
In the Amneal case, Teva’s infringement claims successfTeva triggered a statutory stay that blocked approval of Amneal’s generic ProAir inhaler for up to 30 months, meaning the drug may not be approved until February 2026.
In JuneAmnealw JerseTevaderal judge sided with Amneal and the FTC, ruling that five of Teva’s metered-dose inhalAmnealents were “improperly listed.” The court ordered Teva to “correct or delete” the relevant IP.
Editor's note: This story has been updated withAmnealnt from Teva.
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