Patent law in Europe: What pharmaceutical companies need to know
In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC (“Amgen”) filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar. ...more
Simbrinza® (brinzolamide / brimonidine) - Case Name: Alcon Inc. v. Padagis Israel Pharms. Ltd., Civ. No. 22-1422-WCB, 2025 WL 457119 (D. Del. Feb. 5, 2025) (Bryson, C.J.) Drug Product and Patent(s)-in-Suit: Simbrinza®...more
Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more
The U.S. Supreme Court recently struck down broad patent claims covering a “genus” of antibodies, reaffirming in a 9-0 decision that a patent must “enable” the full scope of its claims (Amgen Inc. v. Sanofi). Amgen, Inc.,...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
Doctrine of equivalents (DOE) can be applied as a mechanism to hold a party liable for patent infringement even if the product or process does not literally infringe a patent claim, if the difference is “insubstantial”....more
There is an undercurrent in patent law these days that litigation favors the defendant. Rather than contending infringement of a few claims of one patent, plaintiffs are now advised to assert multiple claims across several...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
Increasing competition within Europe’s pharmaceutical space makes knowing the market and understanding available patent protections more critical than ever for both well established and new market players. Andreas von Falck...more
In its decision of July 12, 2017 in Actavis v. Eli Lilly, the Supreme Court of the United Kingdom for the first time formally adopted the concept of a doctrine of equivalents when considering what constituted an infringement...more
Worldwide Doctrine of Equivalents and Prosecution History Estoppel - The doctrine of equivalents (DOE) arises in the context of a patent infringement action where the accused product or process does not literally infringe...more
The Federal Circuit and the Supreme Court spent an inordinate amount of time wrestling with each of their conceptions of the scope and application of the doctrine of equivalents a dozen years ago, coming to an accommodation...more
DISTRICT COURT CASES - Humanized Antibody Not Found to Infringe Under DOE - A district court judge granted UCB, Inc.’s (plaintiff) motion for summary judgment that its Cimzia® product, a humanized monoclonal...more
The Federal Circuit availed itself of another opportunity to demonstrate that the Supreme Court's recent decision in Teva v. Sandoz may be relevant in cases that are the exception rather than the rule. The Federal Circuit's...more