News Digest 23.08.2024 — 26.08.2024
Regulators
The Ministry of Economic Development has proposed changing the requirements for applications for a patent for an invention
The Ministry of Economic Development has developed a draft order to amend the rules for drafting, filing and reviewing documents that are the basis for performing legally significant actions for the state registration of inventions. It is also proposed to amend the requirements for documents of an application for a patent for an invention, approved by the order of the Ministry No. 107 of 02/21/2023.
According to the document, when checking the novelty of an invention related to the use of a product or method for a specific purpose, only the features characterizing the purpose will be taken into account.
As patent attorney Alexey Mikhailov told FV, given that the law has different approaches to the extension of patents for methods of treatment and medical use and to the qualification of violations of patents for methods and uses, the proposed change is aimed at ensuring that applicants initially formulate their claims more clearly: so that the formula "for use" does not contain features characteristic of the formula "for a method". "Currently, problems often arise about whether to qualify a formula of an invention that is formally drawn up as a formula "for use", but contains features of a method, for example, if it contains features of administering a drug in a certain dose in a certain mode. At the same time, a patent for a method cannot be extended, but for use - it can," shared Mikhailov.
As follows from the explanatory note, the draft order was prepared to implement paragraph 13 of the action plan for the implementation of the Strategy for the Development of the Pharmaceutical Industry for the Period up to 2030, approved by Government Order No. 753-r dated 30.03.2024. The action plan for the implementation of the Pharma-2030 strategy included 40 events. Among them are priority admission of Russian pharmaceutical products to the Russian market, as well as the training of specialists in the pharmaceutical industry.
Market news
Mishustin instructed to finance the purchase of MRI for the Altai Republican Hospital
Russian Prime Minister Mikhail Mishustin gave a number of instructions on the socio-economic development of the Altai Republic. They included tasks to ensure additional funding for healthcare facilities and priority socially significant expenses. The instructions were given following a working visit to the region on July 25.
In particular, the Ministry of Health and the Ministry of Finance must allocate funds from the government's reserve fund to purchase MRI for the needs of the republican hospital. The draft order must be submitted to the government before September 23.
During a meeting with Mishustin, Acting Head of the Altai Republic Andrei Turchak noted that the hospital is a key medical institution for the region. It is located in a hospital campus, so the buildings are spread over a large area. Moreover, each of them has its own emergency room, which creates difficulties in routing and distributing patients by the severity of the disease.
"The idea was born to build a combined emergency room. Specifically, a modular one, so that it would be cheap and fast enough. Equip it with modern diagnostic equipment - MRI, CT, ultrasound. Today, we only have one MRI machine in this hospital for the entire republic," Turchak noted at the time.
The preliminary cost of the module was estimated at 452 million rubles, the rest of the equipment - at 450 million rubles.
Source: https://t.me/vademecum_live/15384
Other
Sensor for tracking biomarkers of diabetes and cardiovascular diseases developed in Singapore
Continuous and in situ detection of biomarkers in biofluids (for example, sweat) can provide critical data on health, but is limited by the availability of biofluids. Here, we report a sensor design that enables in situ detection of solid-state biomarkers ubiquitously present on human skin. We utilize an ion-electron bilayer hydrogel to facilitate the sequential dissolution, diffusion, and electrochemical reaction of solid-state analytes. We demonstrate continuous monitoring of water-soluble analytes (e.g., solid lactate) and water-insoluble analytes (e.g., solid cholesterol) with ultra-low detection limits of 0.51 and 0.26 nmol cm−2, respectively. Furthermore, the electrochemical interface of the bilayer hydrogel reduces motion artifacts by a factor of three compared to conventional fluid-sensing electrochemical interfaces. In a clinical study, solid-state epidermal biomarkers measured by our stretchable wearable sensors showed high correlation with biomarkers in human blood and dynamic correlation with physiological activity. These results provide pathways toward versatile biomarker monitoring platforms without the need for biofluid acquisition.
Source: https://www.nature.com/articles/s41563-024-01918-9
Hong Kong-developed stethoscope app detects heart disease
A team of researchers from the Li Ka-shing School of Medicine at the University of Hong Kong has developed an AI-powered mobile app that turns a smartphone into a stethoscope to detect symptoms of heart disease.
The app, called Vitogram, uses AI to analyze heart sounds recorded when a mobile phone is placed on a user’s chest.
“Heart sound analysis provides important health data comparable to that obtained by a doctor using a stethoscope,” said Joshua Ho Wing-kei, an associate professor at the Hong Kong University of Medicine.
Based on a clinical trial at a public hospital in late 2023, the AI achieved 81% accuracy in detecting valvular heart disease in about 363 study participants. The researchers now plan to expand their study to a larger, more diverse cohort and cover more heart disease symptoms.
Meanwhile, Vitome, the subsidiary created to commercialize Vitogram, is preparing to launch its stethoscope mobile app overseas, specifically in Singapore and Malaysia, in partnership with healthcare organizations.
As of 2020, heart disease is the third leading cause of death in Hong Kong.
During the pandemic, many cases are said to have been missed as people were prohibited from undergoing in-person checkups. This inspired HKUMed to conduct initial research into turning mobile phones into stethoscopes, which would allow communities to easily detect heart disease at an early stage.
“This breakthrough technology can help detect hidden heart valve diseases in patients in the community, encouraging them to seek medical attention at an early stage,” added Dr. Wong Chun-ka, a cardiologist and associate professor of clinical medicine at HKUMed.
The app, which allows for regular self-checkups, is expected to help people better manage their heart health and further prevent the potential progression of existing heart conditions.
Study: Half of US-Approved Medical AIs Were Trained on Generated Data
Scientists from the University of North Carolina analyzed data on the development of 521 medical devices using artificial intelligence (AI) and found that about half of the tools cleared by the Food and Drug Administration (FDA) were trained on generated data, rather than on information from a real patient. For example, the systems used “phantom images” or AI-generated images, which technically did not meet the requirements for clinical validation.
The study found that only 22 of all AI systems (4.2% of the total) had undergone full-fledged clinical trials. At the same time, about 43% (226 out of 521) of the algorithms did not have any publicly available data on their effectiveness in practice. The scientists hope that their findings will encourage the FDA and developers to improve the reliability of device authorization.
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