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Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., Appeal No. 2023-2357 (Fed. Cir. June 4, 2025) In this week’s Case of the Week, the Federal Circuit affirmed a final judgment that Moderna’s mRNA-based COVID-19 vaccine did...more
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
In the last few weeks, the PTAB has granted institution of eight IPRs filed by Merck on Johns Hopkins patents directed to methods of treatment using pembrolizumab. The eight patents are generally directed to methods...more
We were so pleased to have the opportunity to address InformaMarkets’ 13th Annual Pharma IPR Conference in Mumbai on legal challenges to polymorph patents. Patents covering one or more crystalline forms of a drug substance at...more
Precedential and Key Federal Circuit Opinions - MALVERN PANALYTICAL INC. v. TA INSTRUMENTS-WATERS LLC [OPINION] (2022-1439, 11/1/2023) (Prost, Hughes, and Cunningham) - Prost, J. The Court vacated the district court’s...more
We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more
We previously reported on patent infringement litigations between Alnylam and Moderna. Below we provide updates on two proceedings involving the mRNA vaccine producer Moderna....more
Last week, Canada-based Acuitas Therapeutics, Inc. (Acuitas) filed a complaint in the District of New Jersey for declaratory judgment of non-infringement and invalidity against Arbutus Biopharma Corp. and Genevant Sciences...more
Case Name: Astellas US LLC v. Hospira, Inc., No. 18-cv-1675-CFC, 2022 WL 1591277 (D. Del. May 19, 2022) (Connolly, J.) Drug Product and Patent(s)-in-Suit: Lexiscan® (regadenoson); U.S. Patents Nos. 106,183 (“the ’183...more
Case Name: Horizon Medicines LLC v. Alkem Labs. Ltd., No. 2021-1480, 2021 WL 5315424 (Fed. Cir. Nov. 16, 2021) (Circuit Judges Dyk, O’Malley, and Hughes presiding; Opinion by Dyk, J.) (Appeal from D. Del., Andrews, J.)...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
Precedential Federal Circuit Opinions - CAP EXPORT, LLC v. ZINUS, INC. [OPINION] (2020-2087, 5/5/21) (Dyk, Bryson, Hughes) - Dyk, J. Affirming decision to set aside judgment and injunction pursuant to Federal Rule of...more
On December 24, 2020, the Federal Court issued a decision in a patent infringement action pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations relating to silodosin (Allergan’s RAPAFLO): Allergan...more
Recently, the Federal Circuit issued its holding in a case dealing with asserting claims of an extended patent covering administration of dimethyl fumarate formulations to treat multiple sclerosis (MS). Dimethyl fumarate...more
The Federal Circuit affirmed the grant of a defendant’s Rule 12(c) motion for judgment on the pleadings based on non-infringement, holding that under the plain text of patent term extension (PTE) statute an accused drug...more
On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss...more
On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more
As we have previously reported on Sandoz’s Biologics License Application (“BLA”) for its proposed biosimilar to Neulasta® (pegfilgrastim), Sandoz received a complete response letter from FDA, and had resubmitted its...more
HZNP Medicines LLC, Horizon Pharma USA, Inc. v. Actavis Laboratories UT, Inc. Before Prost, Newman, and Reyna. Appeal from the District Court for the District of New Jersey. Summary: Claims using “consisting...more
INTRODUCTION & BACKGROUND - On May 8, 2019 in Amgen, Inc. v. Sandoz International GmbH, the Federal Circuit Court affirmed the district court’s judgment, concluding that the district court correctly construed the claims and...more
On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. ...more
A recent case at the U.S. District Court for the District of Delaware demonstrates how nuanced safe harbor protection under 35 U.S.C. § 271(e)(1) "non-infringement" can be for a pharmaceutical company developing a biosimilar...more
As we have previously covered, last month the court in Janssen v. Celltrion (D. Mass., J. Wolf) issued a memorandum opinion granting Celltrion’s motion for summary judgment of non-infringement of the sole remaining...more
As we previously reported, the district court granted Sandoz’s motion for summary judgment of non-infringement in the ongoing Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars....more
On May 29, 2018, a week-long bench trial began before Judge Andrews in Sanofi-Aventis U.S. LLC v. Merck Sharpe & Dohme Corp. in the District of Delaware. As we reported here, Sanofi had sued Merck for patent infringement...more