Bayer Files ANDA Complaint Against Mylan

On Thursday, Bayer Pharma AG filed a complaint against fellow pharmaceutical company Mylan Pharmaceuticals Inc. in the Northern District of West Virginia. The plaintiff alleged that the defendant is infringing on its patent for the drug Xarelto, which the plaintiff has owned the patent for since November 10, 2020.

This suit comes in response to a letter sent by Mylan notifying Bayer that it submitted an abbreviated new drug application (ANDA) to the Food and Drug Administration (FDA) in an attempt to engage in commercial manufacturing of generic 2.5 mg rivaroxaban tablets, which is a blood thinner used to treat and prevent blood clots and can reduce the risk of major cardiovascular events. The ANDA was submitted pursuant to the Hatch-Waxman Act, which sets forth the procedure for regulatory approval and commercial marketing of pharmaceuticals, including generic drugs. 

Under the Hatch-Waxman Act, each ANDA must include a certification or statement for each patent listed in the Orange Book. In this case, the defendant is citing paragraph IV of 21 U.S.C. Sec. 355(j)(2)(a)(vii), which states that the patent is not valid or will not be infringed by the new drug. After receiving the notice, Bayer, the  holder of New Drug Application (NDA) on Xarelto, decided to file the lawsuit out of fear that not doing so would result in great financial loss.

The plaintiff stated that contrary to the claims made in the notice letter, the defendant’s generic version of the drug does directly infringe upon claims within its patent and its relation to their brand name drug Xarelto. Bayer argued that this ANDA was filed for the specific purpose of infringing upon the patent and will do so immediately once it is approved. 

The plaintiff stated that the filing was dishonest on the defendant’s part because Mylan made it for the sole purpose of infringement. The plaintiff said the defendant’s product has no non-infringing uses and had no reason to think that it did. The plaintiff added it fears that Mylan’s intent to manufacture, offer for sale, sell, distribute, and/or import their ANDA Products, thus infringing on the patent, will cause substantial and irreparable harm to Bayer.

The plaintiff requests that its accusation of infringement is affirmed and that there is an injunction enjoining Mylan, and all persons acting in concert with Mylan, from the commercial manufacture, use, sale, offer for sale, or importation into the United States of Mylan’s ANDA Products, or any other drug product whose use is covered by the patent.

The plaintiff is represented by Williams & Connolly, Simmerman Law Office, Bailey & Glasser, Carey, Douglas, Kessler & Ruby, and Sidley Austin.