Patents, Proposed Legislation, Food and Drug Administration (FDA)

Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

Latham & Watkins LLP on 6/24/2025

President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more

Senate Seeks to Reduce Biosimilar Prices by “Pruning” “Patent Thickets”

Knobbe Martens on 9/5/2024

On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological...more

PTAB/USPTO Update - October 2021

WilmerHale on 10/5/2021

USPTO News - On September 9, 2021, Senators Patrick Leahy and Thom Tillis wrote a letter to Acting Director Andrew Hirshfeld requesting that the USPTO “take steps to reduce patent applicants’ making inappropriate...more

MarkIt to Market® - March 2021

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 4/5/2021

The March 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses fair use cases for photographs and three recent developments in the cannabis space. We also highlight recent accolades earned by Sterne Kessler's...more

Proposed Legislation Would Require Choice Between ANDA Litigation Or AIA Challenges

Foley & Lardner LLP on 6/18/2018

On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge (IPR or PGR), and on...more

Senators Introduce Another Bill to Ban Reverse Payment Settlement Agreements

McDonnell Boehnen Hulbert & Berghoff LLP on 3/15/2013

Last week, Senator Al Franken (D-MN) was joined by Senators David Vitter (R-LA), Dick Durbin (D-IL), Jeanne Shaheen (D-NH), and Bernie Sanders (I-VT) in introducing S. 204, the "Fair and Immediate Release of Generic Drugs...more