Introductory example
Company A is active in medical technology and has developed several procedures:
One of the procedures involves the non-invasive measurement of blood pressure. The starting point is an inflatable cuff that is placed around the patient's arm. By deliberately inflating and deflating the cuff, the blood flow can be controlled and measured via pressure fluctuations in the artery. The procedure provides a reliable determination of systolic and diastolic blood pressure and represents a technical solution for medical diagnostics. Pulse detection is performed using a special and innovative laser measurement.
In the field of diagnostic imaging, our company has developed an innovative procedure that increases the accuracy of MRI examinations. To do this, the patient is administered xenon as a contrast agent prior to imaging. This can be done by inhalation, intravenous infusion, or, in the context of a surgical procedure, by direct administration into a blood vessel close to the heart. The xenon improves the signal quality in the MRI and enables a more differentiated representation of tissue and blood flow structures.
Our company has developed a method for controlling ventilators in intensive care medicine. This method continuously monitors the COâ‚‚ content in the patient's exhaled air. Depending on this value and a calculation formula stored in the control system, the ventilation intensity is automatically adjusted. The method optimizes patient care and contributes to safe and efficient ventilation.
Medical procedures such as surgical, therapeutic, and diagnostic applications are often excluded from protection under patent law, i.e., if an invention claimed in a patent application falls under one of these exceptions, it may not be patented. If a patent is nevertheless granted, it is invalid.
The main reason for this is the freedom of the physician to choose the best treatment method for the patient without patent restrictions. The legislator does not provide patent protection for certain medical procedures. This particularly affects surgical, therapeutic, and diagnostic procedures, both on the human and animal body. These are not to be patentable in order to ensure that medical professionals have unrestricted access to a wide range of treatment methods without being restricted by patents. It is irrelevant whether the procedure is performed by a physician, nursing staff, or a device. The only decisive factor is that the procedure serves to maintain or improve the health of humans or animals.
Devices used in such medical procedures, on the other hand, are not excluded from patent protection. For example, medical devices, scalpels, medicines, and diagnostic aids can continue to be protected. Similarly, substances such as medicines are not covered by the exception for medical procedures.
For example, a blood pressure cuff with special sensors or a ventilator that automatically regulates the air supply based on the COâ‚‚ content may be patentable. Classic instruments such as surgical scalpels with special cutting edges, injection systems, or medication dispensers are also generally eligible for protection.
Diagnostic methods include all methods in which measurements taken on the human or animal body are used to determine certain conditions, which are then compared with standard values in order to diagnose a disease. Diagnostic methods are excluded from patentability if they involve the following steps:
- Interaction with the body (e.g., through a measurement),
- comparison of the measured value with a target value,
- Determination of a pathological condition.
In the blood pressure measurement method using a cuff, blood pressure is determined on the human body. To do this, the cuff is inflated, the pressure is gradually reduced, and the flow noises or pressure fluctuations are measured. This procedure clearly fulfills the first step of a diagnostic method—interaction with the body.
However, further classification is crucial: the procedure itself only provides a measured value (e.g., 140/90 mmHg). However, this measured value is not automatically compared with standard values as part of the procedure, nor is any disease or pathological condition detected. The assessment of whether high blood pressure is present is the responsibility of the physician or a separate diagnostic step.
This means that this is not a complete diagnostic method in the sense of patent law, but merely a technical measurement method. Since the diagnostic step is missing, the blood pressure measurement method does not fall under the exclusion clause for non-patentable diagnostic methods and can therefore in principle be patentable.
Therapeutic methods are also excluded from patent protection if they include at least one step aimed at improving health. The purpose of a therapeutic method is always to cure, alleviate, or prevent disease. Even prophylactic measures such as taking medication to prevent disease are considered therapeutic and are also not patentable.
The procedure for ventilating a patient falls under the category of therapeutic methods, as it is directly aimed at preserving life and improving health. The aim of ventilation is to ensure the supply of oxygen to the body and the removal of carbon dioxide. The procedure therefore serves either to cure (e.g., in the case of acute respiratory problems), alleviate (e.g., in the case of chronic lung disease), or prevent serious consequences such as oxygen deficiency and organ failure.
Even though ventilation technically consists of measurements, controls, and regulations, the purpose of the procedure is clearly therapeutic. Adjusting the ventilation intensity based on the measured COâ‚‚ content is not only an abstract technical optimization, but also specifically aims to maintain the patient's health and stabilize them. Therefore, despite its technical elements, this procedure is not patentable.
Most surgical procedures serve both diagnostic and therapeutic purposes. They are therefore generally covered by the prohibition on surgical and therapeutic procedures, and a separate examination of the surgical nature of a procedure is not necessary.
An example of a surgical procedure without therapeutic effect is the imaging procedure for visualizing blood vessels, which requires the injection of radioactive xenon into the open heart or a blood vessel close to the heart in preparation. This would be considered surgical due to the high intensity of the procedure and the high risk associated with it.
Surgical procedures must exceed a certain intensity threshold in order to be excluded from patent protection. Simply piercing the skin for an injection is not sufficient to be considered surgical.
A modified imaging procedure in which xenon is injected into the veins in preparation for imaging would not be surgical due to the lack of corresponding intensity of intervention in the human body (and, due to the lack of healing effect of xenon in the veins, probably not therapeutic either).
In all medical exceptions, it is possible to exclude individual variants that fall under the exceptions by means of disclaimers. This reduces the patent claim to those variants that are not excluded, i.e., that are patentable.
The patent claim for the imaging method in which xenon is administered in preparation for imaging, without specifying the specific method of administration, could be limited to non-invasive methods of administration.
