News & Analysis as of

Hatch-Waxman Life Sciences Federal Trade Commission (FTC)

American Conference Institute (ACI)

[Event] 21st Annual Conference on Paragraph IV Disputes - April 29th - 30th, New York, NY

Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit: Patent Must Claim Active Ingredient for Orange Book Listing

On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more

Axinn, Veltrop & Harkrider LLP

Hatch-Waxman Overview

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...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

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

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - October 2023

WilmerHale on

This marks the second issue of WilmerHale’s The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences, a monthly bulletin that will highlight developments in the antitrust and life sciences space. We will...more

Troutman Pepper Locke

FTC Issues Policy Statement Confirming Its Position That Improperly Listing Patents in the Orange Book May Be Considered a...

Troutman Pepper Locke on

The Federal Trade Commission (FTC) has released a new Policy Statement addressing one of its long-standing concerns in the pharmaceutical industry: the improper listing of patents in the Orange Book. In an open meeting of the...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Master Symposium - September 21st - 22nd, Chicago, IL

ACI’s 8th Annual Paragraph IV Disputes Master Symposium returns in person to Chicago on September 21-22! Join leading pharmaceutical patent litigators for brand name and generic drug companies to receive up-to-the-minute...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for December 2018?

This month we highlight two Federal Circuit obviousness-type double patenting decisions. CASES - Federal Circuit - Section 156 Patent Term Extension and Obviousness-Type Double Patenting - Novartis AG v. Ezra...more

Jones Day

Antitrust Alert: New Law Requires Disclosure of Biologic Patent Settlement Agreements to Antitrust Authorities

Jones Day on

Last week, the Patient Right to Know Drug Prices Act ("Act") became law. The Act requires pharmaceutical companies to disclose to antitrust agencies agreements between biologic and biosimilar companies that relate to the...more

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