Patent law in Europe: What pharmaceutical companies need to know
Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a...more
Case Name: Azurity Pharms., Inc. v. Alkem Labs., Ltd., No. 20-cv-1094, 2022 WL 605746 (D. Del. Jan. 31, 2022) (Goldberg, J.) Drug Product and Patent(s)-in-Suit: Firvanq® (vancomycin HCl); U.S. Patents Nos. 10,493,028 (“the...more
Case Name: Almirall, LLC v. Torrent Pharms., Ltd., Civ. No. 20-1373-LPS (D. Del. July 13, 2021) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Aczone® Gel, 7.5% (Dapsone); U.S. Patent No. 9,517,219 (“the ’219 patent”)...more
Duexis® (ibuprofen / famotidine) - Case Name: Horizon Medicines LLC v. Alkem Labs. Ltd., No. 18-1014-RGA, 2020 WL 7022591 (D. Del. Nov. 30, 2020) (Andrews, J.) ...more
2020 has been referred to as an unprecedented year for the world in so many ways—the pandemic, the California and Washington fires, the racial justice protests and calls to action—but that didn’t stop the Federal Circuit from...more
In a Hatch-Waxman case, the U.S. Court of Appeals for the Federal Circuit found that the use of a claimed step, characterized as the “antithesis” of a limitation in the asserted claim, nonetheless satisfied that limitation...more
In This Issue: ..News From the Bench: - Clarification of the “Vitiation Test” when applying the Doctrine of Equivalents. - The “Success More Likely Than Not” and “Ordinary Observer” Standards for a...more