On Tuesday in the District of Delaware, Boehringer Ingelheim Pharmaceuticals Inc. (BIPI) and its affiliates filed a complaint against a generic drug manufacturer with allegations that the generic company has infringed the plaintiffs’ patents covering diabetes drug Trijardy XR.
The plaintiffs own or are assignees of United States Patent Nos. 8,551,957; 9,155,705; 9,415,016; 9,949,998; 10,022,379; 10,258,637; and 10,406,172 covering Trijardy XR, all of which were issued by the U.S. Patent and Trademark Office between 2013 and 2019, the complaint said. BIPI also holds New Drug Application (NDA) No. 212614 for empagliflozin-linagliptin-metformin hydrochloride extended-release tablets in various dosages, sold under the brand name product. The plaintiffs’ drug patent information is listed in the Food and Drug Administration (FDA)’s database.
According to the complaint, Lupin Ltd., an India-based company and the parent to U.S.-based Lupin Pharmaceuticals Inc., submitted Abbreviated New Drug Application (ANDA) No. 215072 in order to start manufacturing and selling a generic version of Trijardy XR. The plaintiffs said they knew of the defendants’ intent to circulate the generic products because Lupin sent letters in early March 2021 that contended that certain claims of the patents-in-suit are “invalid or will not be infringed by the commercial manufacture, use, or sale of the Lupin ANDA products,” the complaint said. The plaintiffs argued otherwise, stating that the defendants’ ANDA products infringe various claims of the plaintiffs’ patents given their bioequivalence to Trijardy XR.
BIPI claimed that “Lupin knows that its ANDA Product is especially made or adapted for use in infringing at least one of the claims” of every patent, “either literally or under the doctrine of equivalents; and its ANDA Product is not a staple article of commerce or commodity of commerce suitable for substantial noninfringing use.”
According to the plaintiffs, they will be “substantially and irreparably harmed” if the court does not enjoin Lupin from continuing its alleged infringement of the plaintiffs’ patents. They also requested the “extraordinary” remedy of attorney’s fees, as well as other relief.
The plaintiffs are represented by Morris, Nichols, Arsht & Tunnell LLP.