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.
Medical technologies giant Stryker announced on Tuesday, October 1st, that it completed the acquisition of Vertos Medical for an undisclosed amount. Vertos Medical is a privately held company specializing in interventional pain management solutions for chronic back pain caused by lumbar spinal stenosis.
CROCS, INC. v. EFFERVESCENT, INC.
Before Reyna, Cunningham and Albright. Appeal from the United States District Court for the District of Colorado.
Summary: A claim that an unpatented product feature is “patented,” “proprietary,” or “exclusive” may violate Section 43(a)(1)(B) of the Lanham Act.
Cook Medical recently announced it is selling its lead management portfolio to Merit Medical. Cook Medical is a medical device manufacturer with a portfolio of products used in lead management procedures, including for patients who need a pacemaker or an implantable cardioverter-defibrillator lead removed or replaced. Merit Medical is a manufacturer of disposable medical devices and has products used in interventional, diagnostic, and therapeutic procedures, including in the fields of cardiology, critical care, endoscopy, oncology, and radiology.
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise concerns with the quality and integrity of data generated.” The press release can be found here.
Getinge, a Swedish public limited company, announced on September 11, 2024 that it completed acquisition of Paragonix Technologies, Inc., a U.S. company specializing in organ transport products and services. According to Getinge’s press release, the total purchase price was $477 million.
On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from Syndax Pharmaceuticals), for treatment of chronic graft-versus-host disease (cGvHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
