European patent law excludes scientific discoveries from patent protection. An invention is only protectable if it represents a technical application of the scientific context discovered. The question now is to what extent the technical part of the invention must go beyond the purely scientific discovery for patent protection to be possible.
Patents EP 959 132 B, filed in 1997, protects a nucleic acid that codes for a receptor protein kinase. This nucleic acid can be used as a marker in the diagnosis of a certain leukemic disease (AML) due to genetic changes. The invention is based on the finding that FMS-like tyrosine kinase 3 (FLT3) plays an important role in leukemia.
A nullity action was filed in Germany against this Invivoscribe patent. Among other things, the plaintiff asserted that claim 1 protected a discovery and thus referred to a discovery excluded from patent protection.
The Federal Patent Court rejected this ground for invalidity and – after examining the other invalidity objections – upheld the patent in amended form.
The plaintiff appealed against this decision to the Federal Court of Justice (BGH). However, without success.
The court distinguishes between the discovery as such (which is excluded from patent protection) and the “teaching for technical action, which concerns the use of a discovery to bring about a certain success”. Under European patent law, the technical teaching of this type is indeed eligible for patent protection.
It is not necessary for the technical teaching to have an “inventive surplus” over and above the use of the discovered natural law connection. Every technical action is based on the targeted use of natural laws. Therefore, when assessing the patentability of a teaching, one must not disregard whether the skilled person was aware of a physical, chemical or biological law that forms the basis of the technical teaching.
The BGH expressly distinguishes the European legal situation from the jurisprudence of the US Supreme Court in Mayo v. Prometheus.
Furthermore, it is also not necessary for the claim to mention that the nucleic acid is present in isolated form or is obtained by a technical process. The prohibition mentioned in the Implementing Regulations of the European Patent Convention on patenting the discovery of a gene sequence of the human body only confirms the principle that discoveries as such cannot be patented. In the present case, it is not the discovery of the sequence that is protected, but the teaching that and how the gene sequence can be made technically usable by isolating it. It is the character of every subject-matter claim that it identifies the thing that characterizes the protected technical teaching. The technical teaching is to provide this very thing (by means of a technical process).
Annotation. This judgment is remarkable because the BGH expressly distances itself from the problematic jurisprudence of the US Supreme Court (see our article
Links: juris.bundesgerichtshof.de/cgi-bin/rechtsprechung/document.py