News & Analysis as of

Inter Partes Review (IPR) Proceeding Hatch-Waxman United States Patent and Trademark Office

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Actavis Labs. FL, Inc. v. United States

Actavis Labs. FL, Inc. v. United States, Appeal No. 2023-1320 (Fed. Cir. Mar. 21, 2025) Our Case of the Week, in the words of its author, Circuit Judge Stark, “is not actually a patent case. It is, instead, a tax case.” In...more

Foley & Lardner LLP

Trends In Orange Book and Biologic PTAB Trials

Foley & Lardner LLP on

The USPTO has released an updated report on Inter Partes Review (IPR) and Post Grant Review (PGR) proceedings involving Orange Book or biologic patents, taking into account data through March 31, 2023. Highlights of the...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2023 #4

United Therapeutics Corporation v. Liquidia Technologies, Inc., Appeal Nos. 2022-2217, 2023-1021 (Fed. Cir. July 24, 2023) In the Federal Circuit’s only precedential patent case this week, the Court considered questions...more

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...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

Haug Partners LLP

NHK-Fintiv Frustration: Status of the Current Challenges and the Uncertain Fate of the PTAB’s Discretionary Denial of IPRs

Haug Partners LLP on

Several challenges have been made recently to the Patent Trial and Appeal Board’s (“PTAB’s or Board’s”) controversial practice of denying inter partes review (IPR) petitions based on the status of parallel infringement...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

Troutman Pepper Locke

Why Biotech and Pharma Patents Survive IPR

Troutman Pepper Locke on

When the America Invents Act of 2011 ushered in a number of new administrative procedures for challenging issued patents, the biotechnology and pharmaceutical industries at first seemed largely unconcerned. Originally...more

Goodwin

Issue Twelve: PTAB Trial Tracker

Goodwin on

The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Morrison & Foerster LLP

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

This month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation settlements and perhaps the end of a long-running Mylan venue dispute in Delaware....more

Troutman Pepper Locke

A Stay of Litigation Pending IPR Does Not Provide a Basis For Extending 30-Stay of FDA ANDA Approval

Troutman Pepper Locke on

On December 11, 2015, the United States District Court for the Southern District of Indiana granted a motion to stay a Hatch-Waxman litigation pending the outcome of inter partes reviews (IPRs) on two of the patents-in-suit...more

Troutman Pepper

Post-Grant Challenges in Life Sciences: A Midyear Assessment

Troutman Pepper on

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

McDonnell Boehnen Hulbert & Berghoff LLP

Representatives Seek Protections for Hatch-Waxman and BPCIA in Innovation Act

Last month, in a letter to Congressional leadership, 79 Members of Congress expressed their support for the Innovation Act (H.R. 9) but sought inclusion of language in the bill "to preserve the integrity of the Drug Price...more

McGuireWoods LLP

IPR Broader Review Standard Upheld by Narrow Federal Circuit Majority

McGuireWoods LLP on

On July 8, 2015, the full Federal Circuit decided not to reconsider en banc (before all the judges) the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board’s (PTAB) standard to construe patents broadly for inter...more

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