Merck wins bench trial over patent term extension issue in Hatch-Waxman multi-party dispute involving BRIDION^®

Client(s) Merck & Co., Inc.

Jones Day is representing Merck Sharp & Dohme, B.V. in Hatch-Waxman patent infringement actions originally against 16 generic drug maker defendant groups, relating to the defendant groups' submissions of Abbreviated New Drug Applications (ANDA) to the FDA seeking approval of generic versions of BRIDION^®, a first-in-class agent for the reversal of certain types of neuromuscular blockade induced in adults undergoing surgery. In this consolidated action, a New Jersey district court took up the issue of whether the calculation of Merck's patent term extension (PTE) for its reissue patent No. RE44,733, was invalid. Merck's position was that in calculating the PTE, "the date the patent is issued" refers to the original patent grant date, and that it was entitled to the full five years of PTE that the USPTO granted. Defendants on the other hand alleged that pursuant to Section 156(c) of the Patent Act, PTE calculation must be based on the date the reissued patent issued, and that Merck was entitled to only 686 days of PTE. A one-day bench trial was held on December 19, 2022. The court sided with Merck and found that the PTE as granted was not invalid under Section 282(c). Final judgment was entered in favor of Merck on June 29, 2023. The case is currently on appeal to the Federal Circuit.

In re Sugammadex, No. 2-20-cv-02576 (CCC) (MF) (consolidated) (D.N.J.); Appeal No. 23-2254 (Fed. Cir.)