Much of U.S. patent law jurisprudence still revolves around subject matter eligibility, but a new decision by the Court of Appeals for the Federal Circuit revisits the question of what constitutes obviousness in patent applications. The court remanded the case between Irvine, Calif.-based Axonics Inc. and Dublin-based Medtronic plc to the Patent Trial and Appeal Board (PTAB) after determining that the PTAB judge’s understanding of obviousness is “doubly infected by error” in a decision that seems to offer some much-needed clarity where obviousness is concerned.
The tension of clashing politics, policies and prescription drug pricing is coming to a head as U.S. Sen. Bernie Sanders (I-Vt.) acts on his threat to hold presidential appointments in the health arena hostage until President Joe Biden commits to do more to bring down drug prices.
The black box warning appended to the label of Alzheimer’s disease (AD) drug Leqembi (lecanemab) took some on Wall Street mildly aback but failed to surprise others, as analysts mulled what the full approval, granted July 6 by the U.S. FDA, might mean for other developers in the space.
The U.S. FDA reported July 11 a class I recall for patient return electrodes used during electrosurgical procedures that may burn the patient with sufficient severity to induce a third-degree burn. More than 21,000 of the electrodes, made by Raritan, N.J.-based Ethicon Inc.’s Megadyne division, are subject to the recall, although the agency said the manufacturer is still conducting a root cause analysis of the issue.
Five long years after the publication of the now-notorious Katsanos paper, the U.S. FDA has issued a final determination about whether devices indicated for treatment of peripheral artery disease carry the threat of excess mortality when using paclitaxel as an antiproliferative.
Cymedica Orthopedics Inc. is relaunching its wearable knee pain relief treatment under the Motive Health Inc. brand, following U.S. FDA clearance for direct-to-consumer (DTC) use. The muscle stimulating Motive Knee band is now available without a prescription for anyone suffering from knee pain.
U.S. FDA clearance of Mobi pumped up Tandem Diabetes Care Inc. on Tuesday. The miniaturized insulin pump is indicated for individuals with diabetes, aged 6 years and up, with the FDA action boosting Tandem’s share price from $26.41 to $29.20 in morning trading before falling back to $27.12 by the end of the day.
The U.S. FDA’s draft guidance for patient-matched guides for orthopedic surgical implants is presumably a much-needed document for makers of these guides, and bench testing may suffice for many such applications. However, the draft states that clinical testing may be required when a manufacturer intends to claim that their guides could reduce surgical times.
Theralase Technologies Inc. has pioneered technology said to selectively infiltrate and kill non-muscle invasive bladder cancer (NMIBC) at the cellular level. Bladder cancer generally is the 10th most common cancer in the world (6th in men and 17th in women), and gradually showing up in greater numbers in other patient groups.
South African Rugby and the U.S. National Football League (NFL) are actively studying ways to more quickly and reliably diagnose concussions and find more effective treatment for their sequelae. Researchers at the University of Birmingham and Marker Diagnostics Ltd. have identified a biomarker that signals a concussion has occurred, while a team at Electrocore Inc. is working with the NFL to address post-concussion headaches.
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