News & Analysis as of

Federal Trade Commission (FTC) Abbreviated New Drug Application (ANDA)

Alston & Bird

Health Care Week in Review: Texas Judge Blocked FTC Rule Banning Noncompetes; Biden Administration Announced $1.4 Billion for HIV...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Haug Partners LLP

FTC Opens Investigation for Orange Book Listing of Medical Device Patents After Teva v. Amneal in District of New Jersey

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Summary - On June 10, 2024, the District Court for the District of New Jersey ordered Teva to delist five patents from the Orange Book for ProAir® HFA (albuterol sulfate) Inhalation Aerosol. The patents were directed to...more

WilmerHale

The Interplay Key Decisions at the Intersection of Antitrust and Life Sciences - June 2024

WilmerHale on

Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more

Fenwick & West LLP

New Jersey Federal Court Weighs in on Orange Book Patent Listings

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In recent months, the issue of whether certain patents are appropriately listed in the Food and Drug Administration (FDA) Orange Book, associated with the Hatch-Waxman Act, has garnered the attention of the Federal Trade...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

Akin Gump Strauss Hauer & Feld LLP

Anti-Obesity Medications: Noteworthy Developments as Policymakers Weigh Coverage Considerations

Key Points - GLP-1 agonists have ushered in a new era in anti-obesity medication policy considerations against the backdrop of a continued focus by policymakers on both drug access and pricing. CMS has taken steps to clarify...more

McDonnell Boehnen Hulbert & Berghoff LLP

FTC warns pharma companies it means business with its Orange Book listing policy

Last September, the Federal Trade Commission (FTC) promulgated a “policy statement” entitled “Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book,” regarding the FTC’s allegations...more

Axinn, Veltrop & Harkrider LLP

Will the PTO's Proposed Expansion of Filing Settlement Agreements Help to Reduce Drug Prices?

In a recent Federal Register notice, the PTO announced a proposed rule requiring that any settlement agreement resolving a PTAB proceeding, even if such agreement occurs prior to a decision to institute an inter partes review...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

Axinn, Veltrop & Harkrider LLP

FDA After Chevron

Under the Supreme Court's Chevron doctrine, courts will defer to a federal agency's interpretation of an ambiguous statute unless that interpretation is unreasonable. Chevron U.S.A. Inc. v. Natural Resources Defense Council,...more

American Conference Institute (ACI)

[Event] 20th Paragraph IV Disputes - April 25th - 26th, New York, NY

Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...more

Fenwick & West LLP

FTC Employs New Tactic in Effort Against Drug Makers Alleged to Have Improperly Listed Patents in the FDA’s Orange Book

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On Nov. 7, 2023, the Federal Trade Commission (FTC) announced it is disputing the listing of more than 100 patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,”...more

Hogan Lovells

FTC challenges around 100 FDA Orange Book patent listings

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The U.S. Federal Trade Commission (FTC) announced that it issued warning letters to 10 drug manufacturers and challenged the Orange Book listings for around 100 patents under the U.S. Food and Drug Administration's (FDA)...more

Morgan Lewis - As Prescribed

FDA’s Orange Book Listing Process: FTC Formally Joins the Fray

The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify...more

Dechert LLP

FTC Issues Policy Statement on Patent Listing

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The FTC is focusing its attention on the listing of pharmaceutical patents in the FDA’s Orange Book. Patent listing may be the subject of FTC inquiry even absent infringement litigation enforcing the relevant patents....more

McDermott Will & Emery

Patent Law Principles Apply to Claim Scope: Orange Book Delisting and Listing and Regulations

The US Court of Appeals for the Federal Circuit ordered that the only Orange Book patent asserted in a lawsuit must be delisted since its claims were directed to the computer-implemented distribution system and not a method...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Affirms Delisting of REMS System Patent from FDA Orange Book

On February 24, 2023, the U.S. Court of Appeals for the Federal Circuit, in Jazz Pharmaceuticals, Inc., v. Avadel CNS Pharmaceuticals, LLC, Case No. 23-1186, affirmed a decision from the District Court of Delaware directing...more

Haug Partners LLP

The Sham Litigation Exception after AbbVie - Is the Subjective Element a Sham?

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The Federal Trade Commission (“FTC”) sued AbbVie and Besins Healthcare, co-owners of a patent that covered brand AndroGel, in 2017. The FTC claimed that the manufacturers had brought “sham” patent infringement litigation in...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

McDonnell Boehnen Hulbert & Berghoff LLP

FTC Prevails in Reverse Payment Case

The Federal Trade Commission (FTC) spent the better part of a decade attacking the practice of innovator drug companies settling ANDA litigation by providing payments to generic applicants challenging the validity of Orange...more

King & Spalding

“Purple Book” Patent Listing Under Biological Product Patent Transparency Act: What is Required, and What to Expect?

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The Biological Product Patent Transparency Act (“BPPT”) – tucked into Congress’s omnibus spending bill (“Consolidated Appropriations Act,” H.R. 133, Pub. L. No. 116-260) signed into law on December 27, 2020 – is the...more

White & Case LLP

FTC Publishes Annual MMA Report—Continues to Scrutinize Pharma Patent Settlements

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On December 3, 2020, the Federal Trade Commission (FTC) published its annual report on pharmaceutical patent settlements filed with the FTC under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Trade Commission v. AbbVie Inc. (3d Cir. 2020)

The Federal Trade Commission carried out an (in)famous crusade against reverse payment (more provocatively, "pay for delay") settlements in ANDA litigation for almost a decade before eventually having the Supreme Court see...more

Arnall Golden Gregory LLP

FDA Issues Final Guidance on “505(q)” Citizen Petitions, including Factors to be considered in Evaluating Potential...

FDA recently issued final guidance for industry on citizen petitions and requests for stays of agency action that may delay the approval of certain drug and biological product applications....more

Foley & Lardner LLP

Antitrust Scrutiny of Technology Companies Continues to Expand

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Governmental and private antitrust actions against technology companies expanded in 2018 and 2019, particularly relative to electronics and pharmaceutical companies.  This post provides an overview of several important...more

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