One of the findings from Medtech Day 2020 was that the participants were particularly interested in the pitfalls and complexity of Patent Applications in the medical field. We therefore want to take a closer look at the topic of Patents and Licenses for Medtech companies.

The medtech sector has the second highest number of applications in Europe. However, the hurdles for successful Patents in the field of diagnostic procedures are very high and should not be underestimated:

For example, an Israeli research group has developed a device for diagnosing Alzheimer’s disease. It is based on the fact that Alzheimer’s patients react differently to certain nerve stimulators than healthy people. When a low dose of the nerve stimulator is administered to the patient’s retina, the pupil changes differently to that of a healthy person. The device therefore has a camera that measures the pupil at regular intervals. The measurements are compared with standard data to determine whether the person being examined suffers from Alzheimer’s disease. The European Patent Office has rejected the Patent Application on the grounds that the invention protects a “diagnostic method on the human body”.

But what is classified as a “method of diagnosing the human body”? According to the jurisprudence of the European Patent Office, a diagnostic method has four phases:

1. examination: data collection on the human body.
2. comparison: compare data with standard values.
3. symptom recognition: determine a significant difference to the standard values.
4. diagnosis: deduce a clinical picture from the deviation.

If a method covers all four steps, it is considered a “diagnostic method on the human body” and is excluded from patent protection.

The rejection of a Patents can theoretically be avoided if one of the steps is missing. However, it is of course not enough to simply omit one of the steps, even though it is actually part of the invention. An in-depth analysis of the case is therefore essential to ensure that the patent is granted as well as possible. It is also important to structure the patent specification in such a way that it does not fall within the patentability prohibition in the first place. In order to work through these points professionally, it is advisable to consult a Patent Attorney who already has experience in the medtech Industries. So do your research thoroughly and seek advice to avoid a patent rejection.