News & Analysis as of

Pharmaceutical Industry › Hatch-Waxman › Competition

Hogan Lovells

FTC and DOJ hear from experts on how to increase competition and promote affordability in the U.S. pharmaceutical industry

Hogan Lovells on

The Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) have concluded a series of three listening sessions focused on competition in the pharmaceutical industry. ...more

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

Breaking the Patent Thicket: Why the Proposed ETHIC Act Could Have Big Implications on Pharma Patent Law

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

On July 15, 2025, U.S. Senators Peter Welch (D‑VT), Josh Hawley (R‑MO), and Amy Klobuchar (D‑MN) introduced the ETHIC Act—the Eliminating Thickets to Increase Competition Act (S. 2276)—in the U.S. Senate. The bill is designed...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

Morrison & Foerster LLP

FTC Alleges Improper Orange Book Listing of Drug Delivery Device Patents

Morrison & Foerster LLP on

In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more

Morgan Lewis - As Prescribed

Proposed Antitrust Legislation Targets Pharmaceutical Industry, Would Grant FTC More Powers

Morgan Lewis - As Prescribed on

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse...more

Goodwin

The Biologic Patent Transparency Act: Proposed Revisions to Purple Book

Goodwin on

Earlier this month, a bipartisan group of six senators introduced the Biologic Patent Transparency Act (“BPTA”), which the senators say will “help increase patent transparency, promote biosimilar competition, bring needed...more

Hogan Lovells

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

Hogan Lovells on

On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives...more

Mintz

FTC Hosts Workshop – “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”

Mintz on

On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more

The Volkov Law Group

Super Moon Harkens Low Tide for Hatch-Waxman Patent Disputes

The Volkov Law Group on

This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more

Wilson Sonsini Goodrich & Rosati

FTC Workshop to Revisit Competition Issues Regarding Follow-On Biologics

Wilson Sonsini Goodrich & Rosati on

Five years ago, the Federal Trade Commission (FTC) waded into the debate regarding the benefits and potential competition issues posed by the introduction of "follow-on biologics." Now, some three years after Congress...more

10 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide