News & Analysis as of

Orange Book Life Sciences Competition

Skadden, Arps, Slate, Meagher & Flom LLP

The FTC Challenges Companies’ Allegedly Improper Orange Book Patent Listings

The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more

Foley Hoag LLP

FTC Challenges More Patent Listings in the FDA’s Orange Book

Foley Hoag LLP on

The Federal Trade Commission (FTC) has been busy scrutinizing patent listings in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - April 2024

WilmerHale on

This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more

Hogan Lovells

FTC continues to highlight FDA Orange Book patent listings

Hogan Lovells on

With the recent filing of an amicus brief in a private pharmaceutical patent infringement case, the Federal Trade Commission (FTC) has continued its focus on allegedly “improperly listed” patents in the Food and Drug...more

Sheppard Mullin Richter & Hampton LLP

FTC's Campaign Against Improper Orange Book Listings Continues with Amicus Brief in Teva’s Challenge of Amneal Asthma Inhaler ANDA

The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - January 2024

WilmerHale on

Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision.  On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more

Morgan Lewis - As Prescribed

FTC Policy Statement on Orange Book Listings Brings More Clarity (Sort Of)

With the J.P. Morgan Healthcare Conference taking place in San Francisco this week, what better time for an update on the Orange Book? The US Federal Trade Commission (FTC), supported by the US Food and Drug Administration...more

Knobbe Martens

The Federal Trade Commission Put Brand Drug Manufacturers on Notice About Improperly Listing Patents in the Orange Book and Then...

Knobbe Martens on

The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug...more

Jones Day

FDA Launches Review of Orange Book Patent Listing Practices

Jones Day on

Citing its priority to facilitate the timely development and approval of generic drugs, the U.S. Food and Drug Administration ("FDA") solicits stakeholder input on the types of patents that should be listed in the Orange...more

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