Minor Cannabinoids: Exploring the Science, Legality, & Opportunities
The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more
As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more
As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...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
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
The old adage "Bad cases make bad law" is invoked when the facts of a case lead a court to rule in favor of the particular entities before it rather than applying the law consistently. (Although anyone familiar with recent...more