News & Analysis as of

Patent Invalidity Abbreviated New Drug Application (ANDA) Food and Drug Administration (FDA)

BakerHostetler

A Later-Discovered Improvement to an Invention Cannot Be Used To Reach Back and Invalidate an Earlier-Filed Patent

BakerHostetler on

Novartis markets and sells a combination therapy of valsartan and sacubitril under the brand name Entresto® for the treatment of various forms of heart failure. MSN submitted an Abbreviated New Drug Application seeking...more

Robins Kaplan LLP

Melinta Therapeutics, LLC v. Nexus Pharms., Inc.

Robins Kaplan LLP on

Minocin® (minocycline) - Case Name: Melinta Therapeutics, LLC v. Nexus Pharms., Inc., Civ. No. 21-2636, 2024 WL 4799896 (N.D. Ill. Nov. 15, 2024) (Kness, J.)  Drug Product and Patent(s)-in-Suit: Minocin® (minocycline);...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit Reverses Decision Finding Lack of Written Description for Patent Claiming a Pharmaceutical Composition Comprising...

The Federal Circuit recently reversed a District of Delaware decision that invalidated claims of Novartis’s Orange Book listed patent, U.S. Patent No. 8,101,659 (the “’659 patent”), for its blockbuster drug Entresto®, a...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

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

Foley & Lardner LLP

Federal Circuit Considers Patentability of Overlapping Ranges

Foley & Lardner LLP on

In UCB Inc. v. Actavis Laboratories UT Inc., the Federal Circuit affirmed the district court’s judgement of invalidity on obviousness grounds but reversed the finding of anticipation. In reaching its decision on anticipation,...more

Knobbe Martens

Federal Circuit upholds Millennium’s Patent on Velcade®

Knobbe Martens on

MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC - (Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley) - This case arose out of an ANDA litigation between Millennium and a number of generic-drug companies who sought FDA...more

McDonnell Boehnen Hulbert & Berghoff LLP

Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC (Fed. Cir. 2017)

The Federal Circuit had the opportunity to provide guidance on a question now in its twilight: what is the standard for determining who is the true inventor under pre-AIA 35 U.S.C. § 102(f), in Cumberland Pharmaceuticals...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

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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