FTC’s Rahul Rao On Why Agency Targeted Drug-Device Orange Book Patents

Deputy director of the Bureau of Competition notes in an interview that the FTC focused on older products it felt should have more generic competition in its letters to companies citing improper patent listings. He says it is clear which drug-device combo patents should not be listed.

FTC orange book Rao
• Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

The US Federal Trade Commission took on a new mission when it issued letters to drug manufactures claiming they improperly listed patents pertaining to drug-device combination products in the US Food and Drug Administration’s Orange Book. Lawyers have questioned why the FTC did so without guidance from FDA on what device patents can be listed.

Rahul Rao, deputy director of FTC’s Bureau of Competition, who wrote the letters, talked to the Pink Sheet about why...

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