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Pharmaceutical Patents Enforcement Actions

Goodwin

Antitrust Life Sciences Quarterly Update 2025 Q2

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The first half of 2025 has seen an acceleration of M&A activity, including large-scale life sciences transactions, such as Merck’s $3.9 billion acquisition of SpringWorks, Sanofi’s $9.5 billion acquisition of Blueprint...more

Polsinelli

Device Patents in the Orange Book: May 21, 2025, FTC Warning Letters Appear to have Minimal Impact

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Key Takeaways The Federal Trade Commission (FTC) has continued its scrutiny of Orange Book listings for device patents, signaling bipartisan concern over potential anti-competitive practices....more

Haug Partners LLP

FTC Issues a Third Round of Warning Letters Over Improper Orange Book Listings

Haug Partners LLP on

On May 21, 2025, the Federal Trade Commission (FTC) renewed its efforts to challenge pharmaceutical manufacturers that have allegedly listed patents improperly in the Food and Drug Administration’s (FDA) publication of...more

McDermott Will & Schulte

FTC Revives Orange Book Listing Challenges

On May 21, 2025, the Federal Trade Commission (FTC) issued its third round of warning letters – and its first under the Trump administration – against pharmaceutical manufacturers for allegedly improper listing of patents in...more

Axinn, Veltrop & Harkrider LLP

FTC Peeling Back the Layers of the Orange Book

The Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the “Orange Book,” delaying the entry of generic drug competitors. On May 21, the FTC...more

WilmerHale

Healthcare & Antitrust: What to Expect in the New Trump Administration

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Antitrust scrutiny of healthcare markets is nothing new. The Biden Administration and first Trump Administration focused antitrust enforcement efforts across the healthcare and life sciences industries. The newly installed...more

Hogan Lovells

Republican FTC renews challenges to Orange Book patent listings

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On May 21, 2025 the Federal Trade Commission (FTC) issued renewed warning letters to five companies regarding over 200 allegedly improperly-listed patents in the Food and Drug Administration (FDA)’s Orange Book. Announcing...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Trade Commission Continues Efforts to Delist Drug Device Administration Patents in Orange Book

In the last years of the Biden Administration, the Federal Trade Commission issued a policy statement and sent letters to ten companies having Orange Book-listed patents claiming devices for administering drugs challenging...more

Polsinelli

Orange Book Listings: Republican Led FTC Picks Up Where Democrat Led FTC Left Off

Polsinelli on

Key Takeaways - The Federal Trade Commission (FTC), now under Republican leadership, has continued its scrutiny of Orange Book listings for device patents, signaling bipartisan concern over potential anti-competitive...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

Fish & Richardson

FTC Challenges More Than 100 Patents as Improperly Listed in Orange Book

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On November 7, the Federal Trade Commission announced that it is challenging more than 100 patents held by 10 branded drug companies as improperly or inaccurately listed in the Food and Drug Administration’s Orange Book. The...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

McDermott Will & Schulte

Early Adoption of the Unified Patent Court

The Unified Patent Court (UPC) opened its doors on June 1, 2023. Nineteen actions were initiated during the first six weeks, across a range of subject areas and case values. It had been widely assumed that large companies...more

Jones Day

Vital Signs: Digital Health Law Update Winter 2022

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Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more

Jones Day

Supreme Court Denies Cert On Tribal Sovereign Immunity Question

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On April 15, the Supreme Court denied a petition for certiorari filed by Saint Regis Mohawk Tribe, leaving intact the Federal Circuit’s ruling that tribal sovereign immunity does not apply in inter partes reviews. See Saint...more

Knobbe Martens

The Federal Circuit Finds Tribal Sovereign Immunity does not Apply in IPR

Knobbe Martens on

On July 20, 2018, the Federal Circuit held that tribal sovereign immunity is not available as a defense in IPR. Allergan Pharmaceuticals owned patents that it had asserted in litigation against various generic...more

Knobbe Martens

Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc.

Knobbe Martens on

Federal Circuit Summary - Before Dyk, Moore, and Reyna. Appeal from the Patent Trial and Appeal Board. Summary: Tribal sovereign immunity does not shield Indian Tribe owned patents from IPR. ...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Declares Tribal Sovereign Immunity Cannot Be Asserted In Inter Partes Review Proceedings

U.S. Court of Appeals for the Federal Circuit affirmed a U.S. Patent Trial and Appeal Board (PTAB) decision finding that tribal sovereign immunity does not apply to Inter Partes Review (IPR) proceedings. In so holding, the...more

Jones Day

European Commission Sets its Sights on Allegedly Excessive Drug Prices

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In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more

Robins Kaplan LLP

After Actavis: Crafting Pharmaceutical Settlements that Avoid Antitrust Scrutiny

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Last year’s Supreme Court decision in FTC v. Actavis cleared the way for more antitrust challenges to settlements between generic and branded pharmaceutical companies resolving Hatch-Waxman patent litigation. As a result,...more

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