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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

Mintz - Intellectual Property Viewpoints

Regulation, Enforcement, and Associated Challenges: Part II

Given the continued challenges in policing the burgeoning ENDS marketplace, as previously discussed in Part I of this article, in mid-2024 FDA and DOJ announced the establishment of a federal multi-agency task force to combat...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

A&O Shearman

Ninth Circuit Affirms District Court’s Rejection Of Private State Law Claims Against Qualcomm

A&O Shearman on

On February 25, 2025, the Ninth Circuit Court of Appeals affirmed the United States District Court for the Northern District of California’s rejection of unlawful tying, exclusive dealing, and unfair competition claims...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

Womble Bond Dickinson

USPTO’s Proposed Terminal Disclaimer Practice: What Happened and What Comes Next?

Womble Bond Dickinson on

On May 10, 2024, the United States Patent and Trademark Office (“USPTO”) published a new proposed rule that would require when a patent applicant submits a terminal disclaimer to obviate non statutory double patenting that...more

ArentFox Schiff

AI Legal Landscape: Top Challenges and Strategies in 2025

ArentFox Schiff on

As artificial intelligence (AI) continues to develop at a rapid pace, even the most sophisticated general counsel (GC) and in-house legal teams will be hard pressed to keep up with the evolving legal landscape....more

Skadden, Arps, Slate, Meagher & Flom LLP

Intellectual Property: Appointments, AI Policies, Patent Bills and FTC Action Could Shake Up the Field

Executive orders and other developments suggest changes are in store in the intellectual property (IP) sphere, but the exact shape of the changes is not yet clear. New administration, new leadership: President Donald Trump...more

Jenner & Block

Jenner & Block Japan Newsletter - January 2025

Jenner & Block on

Welcome to the January 2025 edition of the Jenner & Block Japan Newsletter, a publication containing updates about legal developments in the United States that may be noteworthy to our clients and other leaders in the...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

Ropes & Gray LLP

Expected Changes to IP Policy under the Second Trump Administration

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Intellectual property (“IP”) policy does not weigh heavily on most voters’ minds, and so is not often addressed in presidential campaigns. This past campaign was no different – President-elect Donald Trump did not expressly...more

White & Case LLP

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

White & Case LLP on

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

Vinson & Elkins LLP

Trump Administration 2.0 – Tech Transactions Update

Vinson & Elkins LLP on

The incoming Trump administration is expected to make several policy changes likely to impact tech transactions. President-elect Donald Trump has promised to reduce regulation and cut federal bureaucracy, which he says have...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

Perkins Coie

How the Trump Administration May Affect AI Policy on Intellectual Property and Deepfakes

Perkins Coie on

As President-elect Donald Trump prepares for his second term, his administration is poised to influence the future of policy surrounding artificial intelligence (AI) and intellectual property (IP), including regulations...more

WilmerHale

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

WilmerHale on

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

Kohrman Jackson & Krantz LLP

Beyond Money: The Rise of Branding as the Ultimate Asset

Attention is the hottest commodity any company can acquire today. How can you capture attention in an increasingly competitive market where individuals have more information and access than ever before? By crafting a...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

Kramer Levin Naftalis & Frankel LLP

Artificial Intelligence Quarterly Update

In this quarterly update, we review the latest developments in three subjects salient to corporate use of artificial intelligence (AI). First, we discuss the risks associated with AI, the case for board oversight and how the...more

Sheppard Mullin Richter & Hampton LLP

The Rise of Trade Secret Litigation

Legal regimes are shifting, including in the intellectual property world as businesses increasingly seek the protection of trade secrets rather than patents to secure their confidential information. When the Defend Trade...more

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