IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
On March 21, the Court of Appeals for the Federal Circuit held in a precedential opinion that legal fees incurred by generic drug companies in defending against patent infringement suits brought under the Hatch-Waxman Act...more
In Actavis v. U.S., a case at the intersection of tax law and patent law, the Federal Circuit held that generic drug companies’ Hatch-Waxman litigation expenses are “ordinary and necessary business expenses” and can be...more
The US Tax Court determined that a pharmaceutical manufacturer’s legal expenses incurred to defend against a patent infringement suit were eligible for an immediate deduction as ordinary and necessary business expenses, while...more
Abbreviated new drug (ANDA) applicant Amneal petitioned for an inter partes review (IPR) of Almirall’s patent listed in the Food and Drug Administration’s (FDA) Orange Book for a prescription drug to treat acne. Almirall...more
In Amneal Pharmaceuticals LLC v. Almirall, LLC, the Federal Circuit recently found 35 U.S.C. § 285 did not authorize the Court awarding attorney’s fees for conduct occurring at the PTAB. No. 2020-1106, 2020 WL 2961939, at *2...more
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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