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Purple Book Food and Drug Administration (FDA) Patent Trial and Appeal Board

Venable LLP

Venable’s BiologicsHQ Monthly Injection - June 2024

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Venable’s BiologicsHQ Monthly Injection – June 2024...more

Goodwin

USPTO Outlines New Initiatives Regarding Drug Pricing

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On July 6, 2022, Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published her response to the letter sent by Janet Woodcock (former acting FDA Commissioner) to the former...more

Mintz - Intellectual Property Viewpoints

PTAB statistics show interesting trends for Orange Book and biologic patents in AIA proceedings

The Patent Trial and Appeal Board (“PTAB”) regularly tracks statistics regarding administrative trials conducted under the processes created by the America Invents Act (“AIA”), which provide insight into recent trends...more

King & Spalding

“Purple Book” Patent Listing Under Biological Product Patent Transparency Act: What is Required, and What to Expect?

King & Spalding on

The Biological Product Patent Transparency Act (“BPPT”) – tucked into Congress’s omnibus spending bill (“Consolidated Appropriations Act,” H.R. 133, Pub. L. No. 116-260) signed into law on December 27, 2020 – is the...more

Foley & Lardner LLP

New Orange Book And Purple Book Patent Listing Laws Impose New Requirements

Foley & Lardner LLP on

Earlier this year, two new laws were enacted that impact patent listings in the Orange Book (drugs) and Purple Book (biologics). The Orange Book Transparency Act primarily codifies current FDA practices, but adds a new...more

ArentFox Schiff

Legislative Changes to FDA’s Orange Book and Purple Book Listing Requirements

ArentFox Schiff on

Recent legislative developments include amendments to expand upon Orange Book and Purple Book listing requirements. Amidst the breathtaking sweep of activities in the Trump Administration’s waning days in office, the...more

Goodwin

Legal Developments to Keep an Eye Out for in 2020

Goodwin on

Here are our picks of some legal developments to keep an eye out for in the new year: Federal Circuit Decisions on Bevacizumab and Trastuzumab Preliminary Injunctions: Appeals are pending on the District of Delaware’s...more

Goodwin

An Interview with Prof. Arti Rai about the Role of “Patent Thickets” in U.S. Biosimilar Market Entry

Goodwin on

Last week, Big Molecule Watch sat down with Professor Arti Rai to discuss an article she recently co-authored, “How logically impossible patents block biosimilars.” The article, published earlier this month in the...more

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