News & Analysis as of

Inter Partes Review (IPR) Proceeding United States Patent and Trademark Office Generic Drugs

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

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

Goodwin

An Interview with Rachel Goode, Ph.D, about Biological Patent Thickets

Goodwin on

Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

Goodwin on

As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

Proskauer - The Patent Playbook

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...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

Kramer Levin Naftalis & Frankel LLP

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Bradley Arant Boult Cummings LLP

Federal Circuit Refuses to Resuscitate Prostate Cancer Drug Patent - Intellectual Property News

In a precedential decision delivered this week, the Federal Circuit shot down arguments from Appellants BTG International Limited; Janssen Biotech, Inc.; Janssen Oncology, Inc.; and Janssen Research & Development, LLC (BTG),...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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2018 #4

St. Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc., Appeal No. 2018-1638, -1639, -1640, -1641, -1642, -1643 (Fed. Cir. July 20, 2018} - In a groundbreaking decision issued on Friday, the Federal Circuit held that tribal...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

Foley & Lardner LLP

PTAB Institutes Kyle Bass Lialda Patent IPR

Foley & Lardner LLP on

After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally have made it over the first hurdle. The USPTO Patent Trial...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

Perkins Coie

Inter Partes Review Proceedings: A Third Anniversary Report

Perkins Coie on

When inter partes review (IPR) proceedings became effective in September 2012, few people would have predicted the transformative effect it would have on patents and the litigation landscape. Three years in, IPR has become...more

Foley & Lardner LLP

Board Boots Bass Tecfidera IPR on the Merits

Foley & Lardner LLP on

On September 2, 2015, the USPTO Patent Trial and Appeal Board (PTAB) denied institution of another Inter Partes Review brought by Kyle Bass, the Coalition for Affordable Drugs, and other related entities. In denying the...more

Foley & Lardner LLP

PTAB Denies Institution of Kyle Bass's Ampyra Patent Challenge

Foley & Lardner LLP on

The USPTO Patent Trial and Appeal Board (PTAB) has put an end to Kyle Bass’s Ampyra patent challenge, by denying institution of Inter Partes Review (IPR) proceedings. While many were hoping the PTAB would render a decision...more

Foley & Lardner LLP

Will New PTAB Rules Impact IPRs Filed By Kyle Bass Hedge Fund?

Foley & Lardner LLP on

On August 19th, the USPTO released a new set of proposed rules related to post-grant proceedings before the Patent Trial and Appeal Board (PTAB). Among the many offered rules was the addition of a “Rule 11-type certification”...more

Fish & Richardson

Bass Opposes Sanctions and Defends His Actions at the PTAB

Fish & Richardson on

On July 28, 2015, Celgene filed a motion for sanctions in IPR Nos. 2015-01092 and 2015-01103, proceedings challenging the validity of Celgene patents covering Thalomid®, Revlimid® and Pomalyst®. Celgene specifically...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

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