News & Analysis as of

Proposed Legislation › Pharmaceutical Patents › Food and Drug Administration (FDA)

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

Venable LLP

BiologicsHQ Monthly Injection - March 2025

Venable LLP on

On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more

McCarter & English, LLP

Senate Advances IP and Drug Pricing Legislation Amid Innovation Concerns

McCarter & English, LLP on

A Senate panel has advanced three sets of bipartisan bills purportedly aimed at reforming the intellectual property (IP) landscape and lowering the cost of prescription drugs. Together, these bills seek to address issues with...more

Knobbe Martens

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

Knobbe Martens on

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

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

Legislative Efforts to Remove Impediments to Biosimilar Approvals and Marketing

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

Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more

Foley & Lardner LLP

Senate Judiciary Committee Pushes Pharma Patents and Pricing Bills Forward

Foley & Lardner LLP on

It is hard to predict whether a given bill will gain traction, but when the Senate Judiciary Committee reports out five bipartisan bills targeting pharmaceutical patents and pricing, it seems likely they are determined to get...more

Goodwin

The USPTO’s Increasing Focus on FDA Submissions and the Duty of Disclosure

Goodwin on

​​​​​​​The United States Patent and Trademark Office (USPTO) imposes a Duty of Disclosure, Candor and Good Faith (Duty of Disclosure) on all individuals associated with the filing and prosecution of a patent application...more

Jones Day

Vital Signs: Digital Health Law Update Winter 2022

Jones Day on

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

Zuckerman Spaeder LLP

Senate Tweaks Hatch-Waxman with Bill To Codify FDA’s “Active Moiety” Regulation

Zuckerman Spaeder LLP on

To clarify a long-running, hotly-litigated question regarding when a new drug qualifies for exclusive marketing rights intended to reward innovation, Congress has taken an important step toward amending the Federal Food,...more

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

MarkIt to Market® - March 2021

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

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

Foley & Lardner LLP

Proposed Legislation Would Require Choice Between ANDA Litigation Or AIA Challenges

Foley & Lardner LLP on

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

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