News & Analysis as of

Patent Trial and Appeal Board Orange Book Intellectual Property Protection

Jones Day

USPTO Acting Director Denies IPR Institution Based on "Settled Expectations"

Jones Day on

Under a new U.S. Patent and Trademark Office ("USPTO") policy issued in March 2025, pre-institution inter partes review ("IPR") proceedings are now bifurcated, consisting of a first phase in which the director considers...more

Fish & Richardson

The Most Interesting Appellate Cases of 2024

Fish & Richardson on

Appellate courts issued a variety of notable intellectual property (IP) cases in 2024, including cases touching on Orange Book listings, extraterritoriality, willful infringement, design patent obviousness, and public...more

WilmerHale

Federal Circuit Patent Watch: Orange Book Patents Can Be Delisted If They Do Not Claim Active Ingredient

WilmerHale on

Precedential and Key Federal Circuit Opinions - TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. AMNEAL PHARMACEUTICALS OF NEW YORK, LLC [OPINION] (2024-1936, 12/20/2024) (Prost, Taranto, Hughes) - Prost, J. The...more

Morrison & Foerster LLP - Federal Circuitry

Last Week In The Federal Circuit (July 31 – August 4): Federal Circuit Reminds To Focus On The Claims

This week’s case of the (recent) week could serve as a crash course in several areas of patent law. It touches on Hatch-Waxman litigation and the Orange Book, claim construction, anticipation/obviousness, written description...more

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

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

Robins Kaplan LLP

New ANDA Cases - Spring 2021

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This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

Robins Kaplan LLP

New ANDA Cases - Winter 2021

Robins Kaplan LLP on

Federal District Court Cases That Are Filed Pursuant To The Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more

Cooley LLP

Alert: Orange Book Transparency Act Creates Some New Obligations

Cooley LLP on

The Orange Book Transparency Act of 2020, signed into law on January 5, amends section 505(j) of the Federal Food, Drug and Cosmetic Act, codifying and clarifying some patent listing requirements of existing FDA regulations....more

Polsinelli

The Restasis Patents and Tribal Sovereign Immunity: New Developments

Polsinelli on

The battle between Mylan and Allergan over the six Orange Book patents covering Restasis has taken a next formal step. On Sept. 22, the new patent-owner, the Saint Regis Mohawk Tribe, moved to dismiss Mylan’s requests for...more

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