News & Analysis as of

Pharmaceutical Patents United States Patent and Trademark Office Proposed Legislation

Knobbe Martens

Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul

Knobbe Martens on

The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated...more

Fish & Richardson

The PREVAIL Act Is Back. Will It Prevail This Time?

Fish & Richardson on

On May 1, 2025, Senators Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI) reintroduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. The...more

Knobbe Martens

Renewed Efforts in Congress for Pharmaceutical Patent Reform

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With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent reform is likely on the minds of many in Washington. Prior to this political...more

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

Legislative Efforts to Remove Impediments to Biosimilar Approvals and Marketing

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

Knobbe Martens

“Term Act of 2019” Proposes Shifting Patent Challenge Burdens to Branded Companies

Knobbe Martens on

A new bill introduced in Congress last week may limit the ability of branded pharmaceutical companies to extend the period of exclusivity products beyond the term of a single patent. The bill, titled “Terminating the...more

Knobbe Martens

Proposed Legislation: The Hatch-Waxman Integrity Act

Knobbe Martens on

Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize...more

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