News & Analysis as of

Proposed Legislation Pharmaceutical Industry United States Patent and Trademark Office

Knobbe Martens

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

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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

PREVAIL Act Proposes Significant Changes PTAB Proceedings

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IP rights can be vital to the success of medical device companies.  Significant legislative changes governing some of these rights may be on the horizon.  Senators Coons (Delaware), Durbin (Illinois), Hirono (Hawaii), and...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

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

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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

Goodwin

Bipartisan PACED Act Introduced to Address Sovereign Immunity

Goodwin on

Yesterday, Senator Tom Cotton (R-Arkansas) announced the introduction of proposed legislation, Preserving Access to Cost Effective Drugs Act, which would permit the Patent and Trademark Office and the International Trade...more

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