Bayer, Janssen Pharmaceuticals Sue Mylan for Patent Infringement of Xarelto

On Friday, Bayer Pharma AG, Bayer AG and Janssen Pharmaceuticals, Inc. filed a complaint in the Northern District of West Virginia against Mylan Pharmaceuticals Inc. and Mylan Inc. alleging patent infringement on the plaintiffs’ Xarelto product. 

According to the complaint, Janssen is the holder of the new drug application for Xarelto which has been approved by the FDA. The complaint states that XARELTO is a factor Xa inhibitor and when it is administered orally it reduces the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease. 

The plaintiffs state that Xarelto is backed by the patent entitled “Reducing the Risk of Cardiovascular Events” and was issued and assigned to Bayer Pharma AG on November 10, 2020. Further, the plaintiffs state that Bayer AG is an exclusive licensee of the patent and Janssen is an exclusive sublicensee. 

The complaint states that Mylan Inc. is a corporation in the business of manufacturing and selling generic versions of branded pharmaceutical drugs through various operating subsidiaries including Mylan Pharmaceuticals Inc. The complaint alleges that Mylan Inc. and Mylan Pharmaceuticals Inc. (Mylan) are agents of each other and operate in concert as integrated parts of the same business. 

According to the complaint, on June 1, 2021 Mylan notified Bayer Pharma AG and Janssen that it had submitted to the FDA a new drug application for a generic version of Xarelto. Following the letter the plaintiffs filed a patent infringement suit against Mylan on June 22, 2021 which was later consolidated into a pending multidistrict litigation. Further, Mylan again contacted the plaintiffs on June 21, 2022 stating it had submitted another new drug application for a generic version of Xareltoto manufacture, use and sell the drug and to receive a certification by the FDA that such action will not infringe on the plaintiffs’ patent. 

The complaint argues that Mylan intentionally plans to infringe upon the plaintiffs’ patent through the approval of the new drug application and the manufacture, use and sale of its generic version of Xarelto. Further, the plaintiffs argue that Mylan submitted the new drug applications to the FDA to obtain approval to manufacture, use and sell the generic version of Xarelto prior to the expiration of the plaintiffs’ patent.

Accordingly, the plaintiffs filed the present suit alleging patent infringement and seeking a declaration by the court that Mylan has infringed on the patent along with injunctive relief. The plaintiffs are represented by Williams & Connolly LLP, Simmerman Law Office and Sidley Austin LLP