News & Analysis as of

Inter Partes Review (IPR) Proceeding Generic Drugs Patent Trial and Appeal Board

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

Mirror Worlds Technologies, LLC v. Meta Platforms, Inc., Appeal Nos. 2022-1600, -1709 (Fed. Cir. Dec. 4, 2024) In this appeal from the United States District Court for the Southern District of New York, the Federal...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

Knobbe Martens

Federal Circuit Review - December 2021

Knobbe Martens on

Ranges for Interdependent and Interactive Components Can Be Tricky to Derive - In Modernatx, Inc. v. Arbutus Biopharma Corporation, Appeal No. 20-2329, the Federal Circuit held that a presumption of obviousness based on...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

Akin Gump Strauss Hauer & Feld LLP

Generic Drug Developer Lacks Standing to Appeal Adverse IPR Ruling

The Federal Circuit recently held a generic drug developer lacked Article III standing to appeal an adverse patentability determination by the Patent Trial and Appeal Board (PTAB) because it failed to prove that it suffered...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

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

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

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

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

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit Decision Clarifies When an ANDA Filer May Appeal an Adverse IPR Ruling

In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, generic drug manufacturer Amerigen appealed a decision of the Patent Trial & Appeal Board finding UCB’s patent to certain chemical derivatives of diphenylpropylamines...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

Jones Day

PTAB Upholds GILENYA™ Method of Treatment Patent, Prompting New ANDA Litigation

Jones Day on

In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not unpatentable on three separate grounds. Shortly thereafter, Novartis filed suit...more

Knobbe Martens

The Federal Circuit Finds Tribal Sovereign Immunity does not Apply in IPR

Knobbe Martens on

On July 20, 2018, the Federal Circuit held that tribal sovereign immunity is not available as a defense in IPR. Allergan Pharmaceuticals owned patents that it had asserted in litigation against various generic...more

Knobbe Martens

Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc.

Knobbe Martens on

Federal Circuit Summary - Before Dyk, Moore, and Reyna. Appeal from the Patent Trial and Appeal Board. Summary: Tribal sovereign immunity does not shield Indian Tribe owned patents from IPR. ...more

Knobbe Martens

Federal Circuit Review - May 2018

Knobbe Martens on

Priority Claims Cannot Be Incorporated by Reference - In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited, Appeal Nos. 2016-2707 and 2016-2708, the Federal Circuit held that when a patent for a...more

Foley & Lardner LLP

The Hobson's Choice Of The Hatch-Waxman Integrity Act

Foley & Lardner LLP on

As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...more

Patterson Belknap Webb & Tyler LLP

Senator Hatch’s New Legislation Would Eliminate IPR Challenges by Generics and Biosimilar Makers

Generics and biosimilar makers have increasingly used inter partes reviews (“IPRs”), proceedings made possible by the America Invents Act, to challenge patents protecting innovator small-molecule drugs and biologic medicines....more

Snell & Wilmer

Federal Circuit Considers Possible Tribal Immunity from Inter Partes Review

Snell & Wilmer on

Last week, a Federal Circuit panel considered whether transferring patents to a tribal nation invoked the tribe’s sovereign immunity precluding inter partes review. The panel heard oral argument in Saint Regis Mohawk Tribe et...more

Bradley Arant Boult Cummings LLP

A Wish for Nonexistent Cheap Drugs Is Not Standing to Sue

The recent releases of highly effective, and highly priced, drugs to treat chronic diseases has bred a spate of efforts by activists to disenfranchise drug developers of their patent rights. One recent chapter is instructive,...more

Patterson Belknap Webb & Tyler LLP

PTAB Holds Indian Tribes Don’t Offer an Out from IPR

In a highly anticipated decision on the Saint Regis Mohawk Tribe’s motion to terminate inter partes review proceedings, the Patent Trial and Appeal Board rejected tribal sovereign immunity to IPRs. The PTAB’s decision also...more

Troutman Pepper Locke

Allergan’s Mohawk Gambit May Be Doomed – PTAB Rethinks the Scope of Sovereign Immunity

Troutman Pepper Locke on

A few months ago, the Irish drug company Allergan moved to shield its key patents on its dry-eye drug Restasis from challenge at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent Office by assigning these patents to...more

Foley & Lardner LLP

Key Trends In Pharmaceutical IPRs Filed By Generic Petitioners

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We reviewed a sub-group of two hundred and four (204) IPRs filed by generic drug companies against pharmaceutical patents to assess PTAB outcomes and key trends in dealing with this technology field. The survey captured IPR...more

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