News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Patent Litigation

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - February 2023 #4

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, Appeal No. 2023-1186 (Fed. Cir. Feb. 24, 2023) In this week’s Case of the Week, the Federal Circuit affirmed a permanent injunction requiring appellant Jazz...more

Proskauer - Life Sciences

A Guiding Light for the Research Safe Harbor and “Research Tools”?

Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more

Jones Day

ITC Institutes Investigation Based on Allegation of Drug Sales Without FDA Approval

Jones Day on

Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission (“ITC”) might be able to enter the fray too. On April 18, 2018, the ITC issued a notice...more

Hogan Lovells

Hogan Lovells ITC Section 337 Monthly Highlights

Hogan Lovells on

The latest news round-up from our Hogan Lovells ITC Section 337 practice, including a new section featuring "tips from the bench" by former ITC Judge Theodore (Ted) R. Essex. ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - November 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Biotech Inc. et al. v. Par Pharmaceutical Inc. et al. 1:15-cv-00679; filed August 3, 2015 in the District Court of...more

Foley & Lardner LLP

Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

Foley & Lardner LLP on

Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

Robins Kaplan LLP

Otsuka Pharmaceutical Co., Ltd. v. Burwell

Robins Kaplan LLP on

Case Name: Otsuka Pharmaceutical Co., Ltd. v. Burwell, Civ. No. GJH-15-852, 2015 U.S. Dist. LEXIS 68230 (D. Md., May 27, 2015) (Hazel, J.) - Drug Product and Patent(s)-in-Suit: Abilify® (aripiprazole); N/A - Nature...more

Robins Kaplan LLP

Classen Immunotherapies, Inc. v. Elan Pharms., Inc.

Robins Kaplan LLP on

Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., 786 F.3d 892 (Fed. Cir. May 13, 2015) (Circuit Judges Prost and Lourie, and District Judge Gilstrap presiding; Opinion by Lourie, J.) (Appeal from D. Md.,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Allergan, Inc. v. Athena Cosmetics, Inc. (Fed. Cir. 2013) -- FDCA Does Not Preempt State Unfair Competition Laws

If you have ever wondered how popular eyelash enhancers like RevitaLash and Latisse produce their effects, Allergan, Inc. v. Athena Cosmetics, Inc. provides the answer: these products comprise prostaglandin derivatives. The...more

Foley & Lardner LLP

Federal Circuit Upholds RevitaLash Unfair Competition Violation

Foley & Lardner LLP on

In Allergan, Inc. v. Athena Cosmetics, Inc., the Federal Circuit decided an appeal that did not present any patent issues, finding that the allegations of patent infringement in the underlying complaint gave it exclusive...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report -- August 11, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Exela Pharma Sciences, LLC v. EKR Therapeutics, LLC et al. - 5:13-cv-00111; filed August 8, 2013 in the Western...more

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