News & Analysis as of

Hatch-Waxman Obviousness Patent Trial and Appeal Board

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

Polsinelli

New PTAB Guidance on Enabling Requirement Under § 102 of the AIA and Construction of Chemical Compound

Polsinelli on

Synopsis: In a recently issued final written decision, the Patent Trial and Appeal Board (the “Board”) found all challenged claims of U.S. Patent No.11,572,334 (“the ’334 patent”) unpatentable.1 The Board’s decision centered...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Master Symposium - September 21st - 22nd, Chicago, IL

ACI’s 8th Annual Paragraph IV Disputes Master Symposium returns in person to Chicago on September 21-22! Join leading pharmaceutical patent litigators for brand name and generic drug companies to receive up-to-the-minute...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

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 2020

PATENT CASE OF THE WEEK - Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020) - In this appeal from Markman and summary judgment opinions by the district court in a...more

Robins Kaplan LLP

Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc.

Robins Kaplan LLP on

PLAINTIFF’S DISCLAIMER OF CLAIMS FOUND INVALID BY THE PTAB MOOTED ANY CONTROVERSY BEFORE THE APPELLATE COURT ASSOCIATED WITH THAT PATENT, AND A SECOND PATENT-IN-SUIT WAS NOT INVALID BECAUSE THE DISTRICT COURT DID NOT ERR IN...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - August 2019 #3

PATENT CASE OF THE WEEK - Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories, FL, Inc., Appeal No. 2018-1221 (Fed. Cir. Aug. 15, 2019) - This week’s Case of the Week focuses on issues relating to written...more

Knobbe Martens

Federal Circuit Review - February 2019

Knobbe Martens on

PTAB May Invalidate Claims on Reconsideration Based on Grounds Raised in the Institution Decision that Were Not Originally Instituted - In AC Technologies S.A., V. Amazon.Com, Inc., Blizzard Entertainment, Inc., Appeal No....more

McDermott Will & Emery

ANDA Applicant Has Standing to Appeal IPR Decision, Even with Only Paragraph III Certification

The US Court of Appeals for the Federal Circuit found that a failed inter partes review (IPR) petitioner that maintained a Paragraph III certification had sufficient standing to appeal an adverse decision, but affirmed the...more

Knobbe Martens

Amerigen Pharmaceuticals v. UCB Pharma GMBH

Knobbe Martens on

Federal Circuit Summary - Before Lourie, Chen, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: A generic pharmaceutical company had standing to appeal the Board’s decision in an IPR that claims of a...more

King & Spalding

Federal Circuit Rules On Standing To Appeal From PTAB In The Hatch-Waxman Context, And Addresses Obviousness Challenges To Prodrug...

King & Spalding on

On January 11, 2019, the U.S. Court of Appeals for the Federal Circuit issued a precedential opinion affirming the decision of the Patent Trial and Appeal Board (“PTAB”) in an inter partes review proceeding (“IPR”) finding...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for August 2018?

This month we highlight a district court opinion from Judge Dyk, sitting by designation, denying a preliminary injunction in a brand-vs-brand litigation, and a lengthy district court opinion from Judge Bryson, sitting by...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for July 2018?

This month, we highlight significant developments from July 2018, including the FDA’s Biosimilar Action Plan for “reducing gaming of FDA requirements or other attempts to unfairly delay competition” and the much anticipated...more

Morrison & Foerster LLP

Hatch-Waxman and BPCIA Developments in May 2018

This month, we highlight significant developments in May 2018, including a stunning reverse payment decision at the FTC, draft guidance from the FDA intended to curb REMS “abuses,” and case law developments at the Federal...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Update -- Biopharmaceutical Edition

Earlier this week, the Patent Trial and Appeal Board ("PTAB" or "Board") handed down what is thought to be the first set of inter partes review ("IPR") Final Written Decisions ("FWDs") in the biopharmaceutical industry. And...more

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