News & Analysis as of

Inter Partes Review (IPR) Proceeding Hatch-Waxman Food and Drug Administration (FDA)

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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2024 #3

CloudofChange, LLC v. NCR Corp., Appeal No. 2023-1111 (Fed. Cir. Dec. 18, 2024) In our Case of the Week, the Federal Circuit addressed the question of divided infringement in the context of system claims. In its...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

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

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

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

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

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

Knobbe Martens

The Supreme Court’s Decisions Not to Hear Patent Cases Leaves Federal Circuit Decisions on Key Questions Intact

Knobbe Martens on

The Supreme Court recently declined to hear several patent cases, thus leaving the decisions by the Federal Circuit intact. Issues that were not taken up by the Supreme Court include (1) whether performing patented methods...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

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