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Federal Trade Commission (FTC) Pharmaceutical Industry Pharmaceutical Patents

Hogan Lovells

FTC continues to focus on competition in pharmaceutical markets, supports FDA guidance on biosimilars

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On August 20, 2024, the Federal Trade Commission (FTC) filed a comment letter in support of the Food and Drug Administration’s (FDA’s) June 2024 draft guidance on biosimilar interchangeability (the “Draft Guidance”). When...more

Goodwin

FTC Comment on FDA Draft Guidance on Interchangeability

Goodwin on

We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more

Venable LLP

FTC Submits Comment Supporting Proposed FDA Guidance Revising Switching Studies for Biosimilar Interchangeability

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On August 20, 2024, the Federal Trade Commission (FTC) submitted a comment supporting the FDA’s June 2024 draft guidance “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that revises the...more

Wilson Sonsini Goodrich & Rosati

[Event] Biotech Summit 2024 - October 9th - 10th, Boston, MA

Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more

White & Case LLP

Three Drug Pricing Litigation Issues to Watch in the Second Half of 2024

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It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more

WilmerHale

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

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Federal Circuit Allows Teva Patents to Remain in Orange Book.  - The Federal Circuit recently granted Teva Pharmaceutical’s motion for a stay of removal of its patents from the Orange Book in its ongoing dispute with...more

Polsinelli

The FTC’s Challenge to the Listing of Device Patents in the Orange Book: What Challenge?

Polsinelli on

On September 23, 2023, the FTC issued a policy statement advising it would be putting market participants on notice that it intends to scrutinize improper Orange Book listings to determine whether such actions constitute...more

Saul Ewing LLP

FTC Supports Proposed PTO Rule Mandating Disclosure of Agreements Between Litigants in Disputes Before the Patent Trial and Appeal...

Saul Ewing LLP on

Introduction - On June 18, 2024, the Federal Trade Commission (“FTC”) unanimously agreed to submit a comment supporting a recent proposed U.S. Patent and Trademark Office (“PTO”) rule that would mandate the disclosure of all...more

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

Holland & Knight LLP

Orange Book Concerns Pick Up as Yet Another Issue for Pharmaceutical Manufacturers

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Pharmaceutical manufacturers are increasingly finding themselves defending decisions to list in the U.S. Food and Drug Administration's (FDA) Orange Book patents that they assert are associated with their products. The...more

Fenwick & West LLP

New Jersey Federal Court Weighs in on Orange Book Patent Listings

Fenwick & West LLP on

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

McDonnell Boehnen Hulbert & Berghoff LLP

FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy

Policy differences are endemic in politics, and the phrase "causing more heat than light" regarding federal drug policy comes readily to mind listening to the rhetoric coming from the Federal Trade Commission in this regard. ...more

Haug Partners LLP

Second Circuit Affirms Dismissal of Bystolic Pharmaceutical Antitrust Class Actions, Holding Plaintiffs Must Plead Facts Showing a...

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On Monday, May 13, 2024, the U.S. Court of Appeals for the Second Circuit affirmed Judge Lewis Liman’s decision dismissing Plaintiffs’ reverse payment class actions for failure to state a claim. In re Bystolic Antitrust...more

Cooley LLP

FTC Continues to ‘Dispute’ Orange Book Device Patent Listings, But Still No Antitrust Enforcement

Cooley LLP on

Over the last eight months, the US Federal Trade Commission (FTC) has focused on what it characterizes as “improper” Orange Book listings and the impacts of such listings on generic entry....more

Mayer Brown

US FTC Continues Aggressive Scrutiny of Pharmaceutical Patents Listed in the Orange Book

Mayer Brown on

On April 30, 2024, the US Federal Trade Commission (“FTC”) announced that it had sent “warning letters” to 10 branded pharmaceutical manufacturers, alleging that the companies had made “improper or inaccurate listing of...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 disputes new slate of Orange Book patents for weight loss, diabetes, asthma, and COPD drugs

Hogan Lovells on

On April 30, 2024, the Federal Trade Commission (FTC) announced that it sent a new set of warning letters to ten pharmaceutical companies. The letters inform the companies that the FTC has notified the Food and Drug...more

Locke Lord LLP

The FTC Strikes Again – Challenging the Listing of 300+ Patents in FDA’s Orange Book

Locke Lord LLP on

On April 30, 2024, the FTC issued a press release and warning letters to ten pharmaceutical companies notifying them that the FTC had “availed [themselves] of the FDA’s regulatory process and submitted patent listing dispute...more

Jones Day

FTC Weighs In on Orange Book Listing of Drug-Device Patents

Jones Day on

On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more

WilmerHale

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

WilmerHale on

Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

Knobbe Martens on

As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

Troutman Pepper

FTC Promotes Next Front in Administration's Efforts to Lower Pharmaceutical Prices: Bayh-Dole Act's "March-In" Rights

Troutman Pepper on

The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...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

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

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