News & Analysis as of

United States Patent and Trademark Office Food and Drug Administration (FDA) 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 -
Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - April 2024 #3

Luv N’ Care, Ltd. v. Lindsey Laurain, Appeal Nos. 2022-1905, -1970 (Fed. Cir. Apr.12, 2024) - In this week’s Case of the Week, the Federal Circuit affirmed the district court’s bench trial decision that unclean hands...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Patent Term Adjustment Results in Invalidity on Obviousness-Type Double Patenting Grounds

The Federal Circuit recently affirmed a United States Patent and Trademark Office (PTO) decision to invalidate four related patents on obviousness-type double patenting grounds (OTDP), holding that any analysis of OTDP for...more

American Conference Institute (ACI)

[Event] 17th Annual Paragraph IV Disputes Conference - April 26th - 27th, New York City, NY

Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more

Goodwin

Celltrion and Hospira Have Launched Inflectra® in U.S.

Goodwin on

This past April, the FDA approved Inflectra® (infliximab-dyyb), Celltrion and Hospira’s biosimilar of Janssen’s Remicade®. According to papers filed in the Federal Circuit this week, Celltrion and Hospira (collectively,...more

McDonnell Boehnen Hulbert & Berghoff LLP

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

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

Foley & Lardner LLP

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

Foley & Lardner LLP on

Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

McDonnell Boehnen Hulbert & Berghoff LLP

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

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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