A high-stakes legal battle has erupted in the pharmaceutical industry, with a leading biopharmaceutical company taking decisive action to protect its intellectual property. On June 13, 2024, AbbVie Inc. and Allergan Pharmaceuticals International Limited filed a complaint in the United States District Court for the Northern District of Illinois against Fresenius Kabi USA, LLC and Fresenius Kabi iPSUM SRL. The plaintiffs accuse Fresenius of patent infringement related to their antibiotic drug AVYCAZ®.
The lawsuit centers on five patents held by Allergan that cover various aspects of AVYCAZ®, a combination drug used to treat serious bacterial infections. These patents are U.S. Patent Nos. 8,471,025; 8,835,455; 8,969,566; 9,284,314; and 9,695,122. According to the complaint, Fresenius has submitted an Abbreviated New Drug Application (ANDA) No. 219325 to the FDA seeking approval to manufacture and sell a generic version of AVYCAZ® before these patents expire.
AbbVie and Allergan allege that this ANDA submission constitutes an act of patent infringement under U.S.C. § 271(e)(2)(A). They argue that if Fresenius is allowed to proceed with manufacturing and selling their generic product before the expiration of the patents-in-suit, it would cause significant harm to their business interests and violate federal patent laws. The plaintiffs further claim that Fresenius's actions are willful and deliberate as they had full knowledge of the existing patents when they filed their ANDA.
The plaintiffs are seeking several forms of relief from the court. They want a judgment declaring that Fresenius’s actions infringe on one or more claims of each patent-in-suit under U.S.C. § 271(e)(2)(A). Additionally, they seek an order delaying any FDA approval of Fresenius’s ANDA until after the expiration of all relevant patents and any extensions thereof. AbbVie and Allergan also request a permanent injunction preventing Fresenius from manufacturing or selling their proposed generic AVYCAZ® product until after these patents expire.
Moreover, should Fresenius engage in commercial activities involving their generic product before patent expiration dates, AbbVie and Allergan demand damages or other monetary relief including costs and attorney fees under U.S.C § 285 for what they deem an exceptional case.
Representing AbbVie Inc. and Allergan Pharmaceuticals International Limited are attorneys Elizabeth J. Holland, Mena J. Gaballah from Allen Overy Shearman Sterling USA LLP in New York City; John T. Bennett and Katherine P. Kieckhafer from Allen Overy Shearman Sterling USA LLP in Boston; Matthew R Miner from Allen Overy Shearman Sterling USA LLP in Washington D.C.; along with Lisa L Furby from Jones Day in Chicago.
This case is being overseen by Judge [Name] under Case ID: Civil Action No:1:24-cv-4914.