Merck's BRIDION^® Hatch-Waxman trial victory on patent term extension issue affirmed at CAFC

Client(s) Merck & Co., Inc.

Jones Day represented Merck Sharp & Dohme, B.V. in Hatch-Waxman patent infringement actions originally filed against 16 generic drug maker defendant groups, relating to the defendant groups' Abbreviated New Drug Applications (ANDA) seeking approval of generic versions of BRIDION^®, a first-in-class agent for the reversal of certain types of neuromuscular blockade in adults undergoing surgery. The district court held a one-day bench trial on December 19, 2022, addressing a single issue: the proper calculation of patent term extension (PTE) for a reissued patent. Merck's position was that in calculating PTE, the statutory language "the date the patent is issued" refers to the grant date of the original patent, and that it was thus entitled to the full five years of PTE that the USPTO granted. Defendants argued that PTE calculation must instead be based on the date the patent reissued, and that Merck was therefore entitled to only 686 days of PTE. The district court sided with Merck and found that the PTE was properly calculated. Defendants appealed to the Federal Circuit, where the USPTO filed an amicus brief supporting Merck's position. On March 13, 2025, the Federal Circuit affirmed the district court, holding that the proper "patent" considered for extension under the PTE statute is "the original patent that includes claims that are directed to a drug product."

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