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United States Patent and Trademark Office › Generic Drugs › Patent Invalidity

The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.... more +
The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.    less -
American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

American Conference Institute (ACI) on

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

Womble Bond Dickinson

2024 Hatch-Waxman Year in Review

Womble Bond Dickinson on

In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between brand-name drugmakers and generics. This landmark legislation, enacted to encourage innovation...more

Bradley Arant Boult Cummings LLP

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

Bradley Arant Boult Cummings LLP on

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

McDonnell Boehnen Hulbert & Berghoff LLP

MBHB Snippets: A review of developments in Intellectual Property Law - Volume 14, Issue 2 (Spring 2016)

McDonnell Boehnen Hulbert & Berghoff LLP on

Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...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

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

McDermott Will & Emery

When a Divisional Is Not a Divisional: No Section 121 Safe Harbor for Reissue Patentee Who Retroactively Omitted New Matter - G.D....

McDermott Will & Emery on

Addressing the “safe harbor” provision under 35 U.S.C. § 121, the U.S. Court of Appeals for the Federal Circuit upheld a district court ruling that a reissue patent was invalid for obviousness-type double patenting. G.D....more

McDonnell Boehnen Hulbert & Berghoff LLP

The Medicines Company v. Hospira (Fed. Cir. 2015)

McDonnell Boehnen Hulbert & Berghoff LLP on

There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more

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