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Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
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
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
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
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
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
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
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
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
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
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
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