Insights

Washington – August 15, 2024: The 2025 edition of The Best Lawyers in America® has recognized 42 Crowell & Moring lawyers as "Best Lawyers" and 29 lawyers as “Ones to Watch.”

Washington – August 17, 2023: The 2024 edition of The Best Lawyers in America® has recognized 47 firm lawyers as "Best Lawyers" and 41 lawyers as “Ones to Watch.”

As reported in earlier Client Alerts, on November 7, 2023, the Federal Trade Commission challenged 100 patents as improperly listed in the Food and Drug Administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations” publication, commonly known as the Orange Book. The FTC sent warning letters to ten drug and medical device manufacturers identifying patents for inhalers, autoinjectors and anti-inflammatory multi-dose bottles that the FTC believes are improperly listed. In response, some manufacturers withdrew their patents, and others agreed to cap certain out-of-pocket costs for their drugs, resulting in a “victory lap” of media activity from the FTC in April.

As reported in an earlier Client Alert, on November 7, 2023, the Federal Trade Commission challenged 100 patents as improperly listed in the Food and Drug Administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations” publication, commonly known as the Orange Book. The FTC sent warning letters to ten drug and medical device manufacturers identifying patents for inhalers, autoinjectors and anti-inflammatory multi-dose bottles that the FTC believes are improperly listed. In the letters, the FTC indicated it is using the FDA’s regulatory dispute process to challenge the listing of these patents in the Orange Book because improperly listed patents may violate antitrust laws and impede competition.    

On November 7, 2023, the Federal Trade Commission (“FTC”) announced it is challenging over 100 patents as improperly listed in the Food and Drug Administration’s (“FDA”) publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is commonly known as the Orange Book. The FTC sent warning letters to ten drug and medical device manufacturers identifying patents for inhalers, autoinjectors and anti-inflammatory multi-dose bottles that the FTC believes are improperly listed. In the letters, the FTC indicated it is using the FDA’s regulatory dispute process to challenge the listing of these patents in the Orange Book because improperly listing patents may violate antitrust laws and impede competition. The FTC’s actions appear to be consistent with its recent and increased scrutiny of the healthcare and pharmaceutical industries.