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Patents Federal Trade Commission (FTC) Pharmaceutical Industry

Troutman Pepper Locke

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition

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On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more

McDermott Will & Emery

New Rx for High Drug Prices? Senate Judiciary Committee Advances Six Bills With Heavy Dose of Options

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The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical...more

Knobbe Martens

Two Bills Introduced to Target “Patent Thickets” and “Product Hopping”

Knobbe Martens on

On March 17, 2025, a bipartisan group of senators introduced two bills intended to decrease the cost of prescription drugs. The sponsors include Chuck Grassley (R-Iowa), John Cornyn (R-Texas), Richard Blumenthal (D-Conn.),...more

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

Fish & Richardson

Recent Decisions and FTC Challenges Dictate Caution When Listing Patents in the Orange Book

Fish & Richardson on

In October 2023, Teva Pharmaceuticals filed a patent infringement lawsuit against Amneal Pharmaceuticals alleging that their generic version of Teva’s ProAir® HFA inhaler infringed upon the asserted claims of U.S. Patent Nos....more

Goodwin

Life Sciences M&A Boom and Other Trends to Watch in 2025

Goodwin on

In mid-January, Goodwin and KPMG brought together innovators, practitioners, regulators, and others for an annual symposium on the future of life sciences and healthcare. This event marked the sixth year that Goodwin...more

Foley & Lardner LLP

Federal Circuit Says Proper Orange Book-Listed Patent Must Claim Active Ingredient

Foley & Lardner LLP on

In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...more

Wolf, Greenfield & Sacks, P.C.

A Look Ahead: Key Intellectual Property Legal Developments in 2024 - and What to Expect in 2025

From potential legal challenges to Chinese biopharma supply chains, Europe’s new Unified Patent Court (UPC), landmark decisions in life sciences, pharma’s Orange Book listings, design patent rejections, and likely shifts at...more

White & Case LLP

A Decade of FTC v. Actavis: The Reverse Payment Framework is Older, but Are Courts Wiser in Applying It

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In 2013, the United States Supreme Court significantly changed the landscape of patent settlements in the pharmaceutical industry with its FTC v. Actavis, Inc. decision. In Actavis, the Court held that certain types of...more

Polsinelli

Federal Circuit Decides Case Involving Orange Book Listing of Device Patents

Polsinelli on

Earlier this year we reported on the Federal Trade Commission’s efforts taken against certain drug manufacturers when listing device patents in the FDA’s Orange Book. We concluded that the efforts to date by the FTC had a...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

WilmerHale

USA: Unpacking the shift – Heightened antitrust scrutiny on Orange Book listings

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Forty years ago, Congress passed the Hatch-Waxman Act, which streamlined the generic drug approval process and revamped how patent infringement claims would be litigated against those prospective generic drug applicants. At...more

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

Defining an Orange Book ‘Drug’

The Federal Circuit heard oral argument on November 8, 2024, grappling with the issue of what patent claims may properly be listed in the Orange Book. In late 2023, Teva filed a complaint for patent infringement in response...more

DLA Piper

Teva Ordered to Delist Inhaler Patents From FDA Orange Book

DLA Piper on

In Teva Branded Pharm. Prods. R&D v. Amneal Pharms. of N.Y., LLC, the US District Court for the District of New Jersey ordered Teva to delist five patents from the Food and Drug Administration (FDA)’s Approved Drug Products...more

Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

Goodwin on

To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

Proskauer Rose LLP

FTC Focus: What Access To Patent Settlements Would Mean

Proskauer Rose LLP on

The Federal Trade Commission has pursued aggressive and creative expansion of its antitrust enforcement efforts under the Biden administration, and the pharmaceutical industry is no exception. Indeed, in a recent interview,...more

Hogan Lovells

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

Hogan Lovells on

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

WilmerHale

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

WilmerHale on

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

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

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

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

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

Axinn, Veltrop & Harkrider LLP

Large and Unjustified: Second Circuit Clarifies Pleading Requirements in Reverse Payments Cases

On May 13—and more than ten years after Federal Trade Commission v. Actavis, the leading U.S. Supreme Court case on reverse payment settlements—the Second Circuit for the first time weighed in on whether (and how) antitrust...more

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