News & Analysis as of

New Legislation Patents Food and Drug Administration (FDA)

McDermott Will & Schulte

New Rx for High Drug Prices? Senate Judiciary Committee Advances Six Bills With Heavy Dose of Options

The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical...more

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

IP Hot Topic: Senate Bill Seeks to Create New Skinny Label Protections

A bipartisan Senate bill dubbed the “Skinny Label, Big Savings Act” was introduced in January. The bill would expand the scope of protection afforded by section viii carve-outs, a mechanism that allows Abbreviated New Drug...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senators Get Their Colleagues to Agree on Drug Patent Litigation Legislation

Recent history of Congress's performance as a legislative body has been, to be kind, mixed, and a great many bills, resolutions, and other activities have appeared to be more for show than to accomplish anything worthwhile. ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senators Get Their Colleagues to Agree on Drug Patent Litigation Legislation

Recently the Senate passed S.150 entitled the Affordable Prescriptions for Patients Act. Those paying attention might recall that Senator Cornyn (R-TX) introduced this bill (joined by Senator Blumenthal (D-CT) and seven other...more

Fish & Richardson

Biosimilars 2022 Year in Review

Fish & Richardson on

2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more

Hogan Lovells

New Orange & Purple Book laws increase transparency of patent information for drugs, biologics

Hogan Lovells on

On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types of patents and exclusivity-related information for approved drugs listed...more

Goodwin

President Signs the Orange Book Transparency Act

Goodwin on

On January 5, 2021, the President signed H.R. 1503 (the Orange Book Transparency Act of 2020). The Orange Book Transparency Act of 2020 clarifies information related to patent listing and the types of patents that should be...more

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