News & Analysis as of

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

ArentFox Schiff

Federal Circuit Affirms ImmunoGen Patent Obviousness

ArentFox Schiff on

In a precedential opinion issued on March 6, the Federal Circuit affirmed the US District Court for the Eastern District of Virginia that the claims in ImmunoGen’s US patent application 14/509,809 (“the ’809 application,”...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

Fish & Richardson

What to Know About the USPTO’s Duty of Candor Guidance Regarding FDA Submissions

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​​​​​​​By now you have seen multiple reports discussing the PTO’s Notice of July 29, 2022, relating to the duties of candor and good faith. Federal Register, Vol. 87, No. 145, July 29, 2022....more

Goodwin

USPTO Outlines New Initiatives Regarding Drug Pricing

Goodwin on

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

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

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

Key Trends in PTAB’s 2021 Orange Book and Biologic Patent Study

The U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) recently released an updated Orange Book patent/biologic patent study on August 11, 2021. This is the third report providing data on post-grant...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

Robins Kaplan LLP

New ANDA Cases - Spring 2021

Robins Kaplan LLP on

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

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

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2020 Decisions: Amneal Pharm. LLC v. Almirall, LLC, 960 F.3d 1368...

Abbreviated new drug (ANDA) applicant Amneal petitioned for an inter partes review (IPR) of Almirall’s patent listed in the Food and Drug Administration’s (FDA) Orange Book for a prescription drug to treat acne. Almirall...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

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

Knobbe Martens

Jazz v. Amneal: When your FDA Submissions are Prior Art

Knobbe Martens on

On July 13, 2018, the Federal Circuit decided Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, affirming the Patent Trial and Appeal Board (PTAB)’s finding of invalidity of certain claims of seven Orange Book-listed...more

Foley & Lardner LLP

FDA Xyrem Meeting Materials Qualify As Printed Publication

Foley & Lardner LLP on

In Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, the Federal Circuit affirmed decisions of the Patent Trial and Appeal Board (PTAB) that invalidated seven Orange Book-listed patents for Xyrem®. The main issue on...more

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