Patents and licenses - pitfalls in diagnostic procedures

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One of the findings from Medtech Day 2020 was that participants were particularly interested in the pitfalls and complexities involved in patent applications in the medical field. We therefore want to take a closer look at the topic of patents and licenses for medtech companies.

 

In the medtech sector, the second-highest number of applications is achieved throughout Europe. However, the hurdles for successful patents in the field of diagnostic methods are very high and should not be underestimated:

For example, an Israeli research group developed an apparatus 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 the patient is administered a low dose of the nerve stimulator to the retina, the pupil changes differently than in a healthy person. The apparatus therefore has a camera that measures the pupil at regular time intervals. The measurements are compared with standard data and from this it can be deduced whether the person being examined has 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 "diagnostic method on the human body"? According to the case law of the European Patent Office, a diagnostic method has four phases:

1. examination: data collection on the human body.
2. comparison: comparing data with standard values.
3. symptom detection: finding a significant difference from the standard values.
4. diagnosis: infer a clinical picture from the deviation.

If a method spans all four steps, then it is considered a "diagnostic method on the human body" and is excluded from patent protection.

The rejection of a patent 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. Thus, a thorough analysis of the case is imperative to ensure patentability as best as possible. It is also important to structure the patent specification in such a way that it does not fall into the patenting ban 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 sector. So do your research thoroughly and get advice to avoid a patent rejection.