This week, we highlight the potential U.S. ban on Apple Watches over patent infringement as well as an analysis of biopharma market cap as it relates to the new U.S. drug price negotiations. We also look at the White House’s new artificial intelligence directive aimed to ensure ethical biotech advancements, and the struggle with standardization in the cell and gene therapy sector. Additionally, we highlight a new wearable ECG technology that signals progress in heart attack prevention.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Potential U.S. ban looms for Apple Watch over Masimo’s pulse oximetry patent infringement claims
Per Fierce Biotech, the U.S. International Trade Commission has found Apple in violation of Masimo’s patents related to the pulse oximetry technology used in the Apple Watch. This ruling, which upholds an earlier decision, could lead to a ban on the import and sale of Apple Watches equipped with this feature. President Biden has 60 days to decide whether to enforce the ban. Masimo argues that the ruling is a significant step in holding Apple accountable for using its patented technology unlawfully, while Apple contends that the ban would hurt consumers and public health, suggesting that Masimo’s actions are aimed at eliminating competition for its own smartwatch. The dispute is part of a broader pattern of patent infringement cases involving Apple, including a previous ITC case concerning ECG technology in the Apple Watch.
Biopharma market cap fluctuates amid new U.S. drug price negotiations
The top 20 global biopharmaceutical companies have experienced market capitalization fluctuations in the third quarter as a response to the U.S. government’s initiation of Medicare price negotiations under the Inflation Reduction Act, according to Pharmaceutical Technology. This has led to a marginal aggregate market cap increase from $3.56 trillion in the second quarter to $3.57 trillion in the third quarter. The industry is adjusting to these changes with some companies experiencing significant growth due to successful acquisitions, drug approvals and promising trial results, particularly in the weight loss drug market. Conversely, others have seen declines due to various factors, including concerns over drug safety and effectiveness. The biopharma sector is now tasked with navigating the financial implications of these pricing pressures and finding innovative ways to sustain revenue in a transforming U.S. drug market.
Biotech and AI: Ensuring a secure and ethical future
The White House has issued an executive order emphasizing the safe and responsible development and use of AI, recognizing its potential to address urgent challenges and its risks if misused. The order outlines a coordinated federal approach to AI governance stressing the importance of safety and security in AI systems, particularly in sensitive areas like biotechnology. It mandates the creation of guidelines and best practices for AI, including the development of resources for generative AI and dual-use foundation models, with a focus on preventing harm in cybersecurity and biosecurity. The order also highlights the need for AI red-teaming, a goal-based adversarial act in which ethical hackers are authorized to emulate real attackers’ tactics, to test for vulnerabilities, especially in models that could pose national security risks. This initiative reflects a commitment to harnessing AI’s benefits while protecting against its potential threats to society and national security.
Navigating standardization challenges in advanced therapy bioprocessing
The cell and gene therapy sector is grappling with the lack of standardized process assays, which affect how contract development and manufacturing organizations adapt to client needs, according to the Genetic Engineering & Biotechnology News. The industry’s tendency to keep assay details proprietary for competitive advantage leads to challenges, particularly for smaller biotech firms that may incur high costs by developing their own methods.
Innovative wearable ECG sensor: A leap towards preventing heart attacks
Researchers from RMIT University in Australia have developed a new wearable electrocardiogram sensor that is compact, lightweight, gel-free and waterproof, offering greater comfort and less skin irritation than existing heart monitoring devices. According to News Medical, this device, weighing only 10 grams, is designed to alert individuals with cardiovascular disease to potential heart attacks, facilitating early medical intervention. The sensor’s unique three ‘dry’ electrodes are thin, highly sensitive, and capable of capturing precise cardiac signals during various activities, including swimming and showering, unlike ‘wet’ electrode devices that can cause discomfort and skin irritation. RMIT has filed for an international patent and is exploring commercialization opportunities for this potentially life-saving technology.
For more insights in life sciences, check out RSM’s industry outlook.
