News & Analysis as of

Reversal Abbreviated New Drug Application (ANDA)

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: First-Filed, First-Issued Patent Sets the Term for Obviousness-Type Double Patenting Analysis Even When Granted...

In a case it described as “‘a prime example’ of when ODP does not apply,” the Federal Circuit recently reversed a decision from the District of Delaware that invalidated a claim for obviousness-type double patenting (ODP),...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2023 #2

VLSI Technology LLC v. Intel Corporation, Appeal No. 2022-1906 (Fed. Cir. December 4, 2023) In this week’s Case of the Week, the Federal Circuit vacated an approximately $2.2 billion damages award against appellant Intel...more

Fitch, Even, Tabin & Flannery LLP

Rehearing Reverses Earlier Federal Circuit Decision Finding Silence Supported Negative Claim Limitation

On June 21, in Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., a reshuffled Federal Circuit panel reversed course on rehearing to find that a negative claim limitation was not supported by silence in the...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - October 2019 #3

PATENT CASE OF THE WEEK - HZNP Medicines LLC v. Actavis Laboratories UT, Inc., Appeal Nos. 2017-2149, et al. (Fed. Cir. Oct. 10, 2019) - In a lengthy decision following a bench trial, the Court addressed a matter of...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Cautions Against Rigid Approach to Prosecution History Estoppel in Fourth Appeal from ALIMTA® Litigations

On August 9, 2019, the United States Court of Appeals for the Federal Circuit, in Eli Lilly & Co. v. Hospira, Inc., Nos. 2018-2126, 2127, 2128, reversed in-part and affirmed in-part a district court’s determination of...more

Hogan Lovells

FDA’s Bendeka decision reverses approvals of Treanda generics

Hogan Lovells on

Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more

Knobbe Martens

Federal Circuit Review - January 2019

Knobbe Martens on

A Post-URAA Patent that Issues After but Expires Before a Related Pre-URAA Patent Is Not a Double-Patenting Reference Against the Pre-URAA Patent - In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc.,...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for November 2018?

Morrison & Foerster LLP on

This month we highlight two reversals by the Federal Circuit and a summary judgment of indefiniteness from New Jersey. CASES - Federal Circuit - Grant of Preliminary Injunction Reversed - Indivior Inc. v. Dr....more

Knobbe Martens

The Medicines Company v. Hospira, Inc.

Knobbe Martens on

Federal Circuit Summaries - Before Dyk, Wallach, and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: A distribution agreement qualifies as an invalidating “offer for sale”...more

Knobbe Martens

Federal Circuit Review - November 2017

Knobbe Martens on

Fractured Federal Circuit Holds Patent Owner Does Not Bear Burden of Persuasion in IPR Motions to Amend - In Aqua Products, Inc. v. Matal, Appeal No. 2015-1177, the Federal Circuit, sitting en banc, held that a patent...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

Foley & Lardner LLP

CAFC Finds ANDA Infringement Despite Differences Between FDA Labeling And Claim Language

Foley & Lardner LLP on

In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and...more

Foley & Lardner LLP

Federal Circuit Finds "Consisting Of" Requires Reversing Infringement Of Shire Lialda Patent

Foley & Lardner LLP on

The Federal Circuit focused on the “consisting of” language in the claims at issue when it reversed the district court’s finding that Watson’s ANDA product would infringe the only Orange Book-listed Shire Lialda patent. In so...more

Foley & Lardner LLP

On Sale Bar Invalidates Safyral, Beyaz Folate Patent

Foley & Lardner LLP on

In Merck & CIE v. Watson Laboratories, Inc., the Federal Circuit found communications between Merck and a potential joint venture partner amounted to a commercial offer to sell that invalidated the Orange Book-listed folate...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

McDonnell Boehnen Hulbert & Berghoff LLP

Cephalon, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

Whether ANDA litigation has had a positive or negative impact on generic drug availability is an open question, in view of several recent reports looking at the effects such litigation has had on both branded and generic...more

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