Market reports indicate the global medical device industry for Q3 2024 saw an increase in merger and acquisition (M&A) activity in terms of value year-over-year. Although deal value decreased compared to…
As the FTC continues to crack down on pharmaceutical manufacturers’ allegedly improper listing of patents in the FDA Orange Book, counsel for Teva and Amneal presented oral arguments in the Court of Appeals for the Federal Circuit on November 8,…
In the ongoing case of Carefirst of Maryland Inc. v. Johnson & Johnson[1], the plaintiffs successfully overcame a motion to dismiss. At the heart of the case is J&J’s legal…
TELEFONAKTIEBOLAGET LM ERICSSON v. LENOVO (UNITED STATES), INC. Before Lourie, Prost, and Reyna. Appeal from the Eastern District of North Carolina. Summary: The threshold requirement for anti-suit injunctions, that the…
UTTO INC. v. METROTECH CORP. Before Prost, Taranto, and Hughes. Appeal from the United States District Court for the Northern District of California. Summary: The district court erred in construing…
On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) released a new web-based interactive tool on the Unified Website for Biotechnology Regulation for companies that develop microbial biotechnology products. The purpose of the tool is to help developers fulfill the regulatory requirements necessary to work with genetically modified microorganisms. The tool defines “genetic modification” as any technique that uses recombinant, synthesized, or amplified nucleic acids to modify or create a genome. “Microorganisms” include prokaryotes (e.g., bacteria and archaea), protists (e.g., amoebas), fungi (e.g., yeast, mold, mushrooms), green and red algae, and viruses or virus-like particles. Through a series of prompts, the tool provides users with information on regulatory requirements and the approval process across agencies. A built-in feedback function allows stakeholders to submit feedback directly to the agencies, which have expressed a commitment to continuing to improve the tool and expand its utility, scope and user base.
The FDA has granted approval for Novocure‘s wearable medical device, Optune Lua, designed to treat advanced non-small cell lung cancer (NSCLC). The device utilizes portable transducer arrays placed on the skin to deliver alternating electrical fields, termed Tumor Treating Fields (TTFs), thereby disrupting malignant cell division while leaving healthy cells largely unaffected.
On October 7, 2024, the 2024 Nobel Prize in Physiology or Medicine was jointly awarded to two American scientists, Victor Ambros (of UMass Medical School) and Gary Ruvkun (of Harvard Medical School), for their discovery of microRNA, a new class of small noncoding RNA molecules, and the role microRNAs play in turning genes on and off, known as gene regulation.
ALEXSAM, INC. v. ATENA, INC.
Before Stark, Lourie, and Bryson. Appeal from the United States District Court for the District of Connecticut.
Summary: A narrowly defined patent license may result in some activity falling within the scope of the patent claims, but outside the scope of the license. Additionally, a trial court’s determination that an allegation in a complaint is merely conclusory and need not be taken as true when evaluating a motion to dismiss is reviewed de novo.
Caldera Medical, Inc. on October 8th, 2024, announced the acquisition of UVision 360, Inc. Caldera Medical develops medical devices for women’s health, including surgical products for the treatment of stress urinary incontinence, pelvic floor disorders, pelvic organ prolapse, and hysteroscopic removal of intrauterine tissue. UVision 360 is a developer of in-office hysteroscopy systems for evaluating and treating uterine conditions.