On Tuesday in the District of Delaware, Pfizer and its subsidiary companies filed a complaint alleging that Zydus Pharmaceuticals and affiliates infringed on two of Pfizer’s patents for Xeljanz XR.
Pfizer holds the new drug application (NDA) for 22 mm tofacitinib citrate extended-release tablets, under the brand name Xeljanz XR, used to treat rheumatoid arthritis and ulcerative colitis, the complaint said. The patents-in-suit corresponding to Xeljanz XR are U.S. Patents Nos. RE41,783 and 6,965,027, which are set to expire Dec. 8, 2025, and March 25, 2023, respectively, according to the Food and Drug Administration’s (FDA) patent publication, the Orange Book.
According to the complaint, Zydus sent a letter on Jan. 7 to notify Pfizer that it had submitted an abbreviated new drug application (ANDA) seeking FDA approval to sell 22 mg tofacitinib citrate extended-release tablets. The defendant claimed in the letter that its generic product would not infringe on the patents-in-suit, arguing that all claims of the patents are invalid; however, Pfizer disagreed.
Pfizer alleged that Zydus’ manufacturing, marketing, and selling of its ANDA product before the expiration of Pfizer’s patents-in-suit is an act of infringement. According to the complaint, Zydus’ conduct is willful given that the patents’ information was listed in the Orange Book before Zydus filed its ANDA.
Pfizer claimed that if Zydus is not enjoined from continuing its actions, it will sell and distribute its generic product in the U.S., an outcome that will “substantially and irreparably” harm Pfizer.
Pfizer is seeking a judgment that Zydus’ ANDA product infringes on the patents-in-suit unless circulated after the patents’ expirations, enjoinment of Zydus and affiliates from manufacturing, selling, and distributing its ANDA product before the patents-in-suit expire, and monetary awards, among other relief.
Pfizer is represented by Morris, Nichols, Arsht & Tunnell.