Insights

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 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.

Just over a week after the Supreme Court’s decision in Arthrex, the USPTO has issued preliminary guidance on how the Office plans to implement the Director-review process required by the Court’s decision. The Office intends to treat the Director reviews much like the current request for rehearing process. Namely, a request for the Director’s review must satisfy the timing requirements of a request for rehearing (37 C.F.R. 42.71(d)), and a timely request for Director review will reset the time for appeal or civil action pursuant to 37 C.F.R. 90.3(b). But unlike requests for rehearing by the panel of administrative patent judges, which must point out an argument or issue that the Board “misapprehended or overlooked,” the Director can review any issue, whether one of fact or law. The Director also has de novo review authority, so need not give deference to the panel’s decisions under review. Further, the Director can initiate a review sua sponte. When sua sponte review is initiated, the parties to the proceeding will be given notice and may be given an opportunity for briefing.