News & Analysis as of

Patents Patent Invalidity Abbreviated New Drug Application (ANDA)

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

Sheppard Mullin Richter & Hampton LLP

UCB, Inc. v. Actavis Laboratories UT, Inc. No. 2021-1924, (Fed. Cir. Apr. 12, 2023)

This case addresses the legal framework for determining whether prior art anticipates a claimed range. The appropriate legal framework applies a different test depending on whether the prior art discloses a point within the...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

Sheppard Mullin Richter & Hampton LLP

2023 Federal Circuit Case Summaries

We are excited to share Sheppard Mullin’s inaugural quarterly report on key Federal Circuit decisions. The Spring 2023 Quarterly Report provides summaries of most key patent law-related decisions from January 1, 2023 to March...more

Robins Kaplan LLP

Vanda Pharms., Inc. v. Teva Pharms. USA, Inc.

Robins Kaplan LLP on

Case Name: Vanda Pharms., Inc. v. Teva Pharms. USA, Inc., Civ. No. 18-651-CFC, 2022 WL 17593282 (Dec. 13, 2022) (Connolly, J.)  Drug Product and Patent(s)-in-Suit: Hetlioz® (tasimelteon); U.S. Patents Nos. RE46,604 (“the ’604...more

McDermott Will & Emery

ANDA Filing Alone Insufficient for Induced Infringement of Method Patent

The US Court of Appeals for the Federal Circuit upheld a district court’s findings of invalidity and noninfringement in a Hatch-Waxman case involving two sets of method patents directed to modulating dosages of pirfenidone, a...more

McDonnell Boehnen Hulbert & Berghoff LLP

Genentech, Inc. v. Sandoz Inc. (Fed. Cir. 2022)

The Federal Circuit recently affirmed a district court judgment of invalidity for obviousness and for noninfringement for a series of patents challenged in ANDA litigation, in Genentech Inc. v. Sandoz Inc.  In doing so, a...more

McDermott Will & Emery

Long-Felt Need Not Felt Long Enough to Overcome Obviousness

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit upheld a finding that patents covering Narcan, a naloxone-based intranasal opioid overdose treatment, were obvious despite evidence of long-felt need. Adapt Pharma Operations...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Approves Generic Restasis

On Wednesday, the U.S. Food and Drug Administration announced approval to Mylan Pharmaceuticals for a generic form of Allergan's RESTASIS® (Cyclosporine Ophthalmic Emulsion 0.05%) product for treatment of chronic dry eye. ...more

WilmerHale

CAFC Patent Cases - October 2021 #2

WilmerHale on

Precedential Federal Circuit Opinions - CELGENE CORPORATION v. MYLAN PHARMACEUTICALS INC. [OPINION] (2021-1154, 11/05/2021) (PROST, CHEN, and HUGHES) - Prost, J. This is a case about venue and pleading under the...more

Kilpatrick

Federal Circuit Reaffirms That There Is No ‘Reasonable Expectation Of Success’ In Trying To Invalidate A Chemical Compound Claim...

Kilpatrick on

The Federal Circuit (in an unpublished opinion) recently reaffirmed the difficulty generic challengers face when trying to establish chemical structural obviousness to invalidate a drug compound patent claim. This recent...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2020 Decisions

[co-author: Kathleen Wills] Last year, the global COVID-19 pandemic created unprecedented challenges for American courts. By making several changes, however, the U.S. Court of Appeals for the Federal Circuit was able to...more

Knobbe Martens

Federal Circuit Review - October 2019

Knobbe Martens on

The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more

McDonnell Boehnen Hulbert & Berghoff LLP

HZNP Medicines LLC v. Actavis Laboratories UT, Inc. (Fed. Cir. 2019)

The Federal Circuit earlier this week affirmed a District Court's decision invalidating almost all of the claims asserted against an ANDA filer, in HZNP Medicines LLC v. Actavis Laboratories UT, Inc.  Nevertheless, because a...more

McDonnell Boehnen Hulbert & Berghoff LLP

Nalproprion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2019)

Last week, the Federal Circuit reversed findings of non-obviousness and affirmed (over Chief Judge Prost's dissent) a finding that claims asserted in ANDA litigation were not invalid for failure to satisfy the written...more

McDonnell Boehnen Hulbert & Berghoff LLP

Dr. Falk Pharma GmbH v. Generico, LLC (Fed. Cir. 2019) - July 2019

The interplay (or perhaps utilization) of inter partes review (IPR) in ANDA litigation was illustrated by the Federal Circuit in last month's Dr. Falk Pharma GmbH v. Generico, LLC nonprecedential decision....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

WilmerHale

Federal Circuit Patent Updates - January 2019

WilmerHale on

Barry v. Medtronic, Inc. (No. 2017-2463, 1/24/19) (Prost, Moore, Taranto) - Taranto, J. Affirming judgement of no invalidating public use of patents related to methods for correcting spinal column anomalies. Also...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

Knobbe Martens

Novartis AG v. Ezra Ventures LLC

Knobbe Martens on

Federal Circuit Summary - Before Moore, Chen, and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: Obviousness-type double patenting does not invalidate an otherwise validly...more

McDonnell Boehnen Hulbert & Berghoff LLP

Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc. (Fed. Cir. 2018)

Last month, in Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc., the Federal Circuit affirmed a decision by the U.S. District Court for the District of Delaware finding that Defendant-Appellant Custopharm Inc. had not...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

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