mardi, février 01, 2011

Germany: Federal Supreme Court: image-guided catheter navigation patentable

Federal Supreme Court: image-guided catheter navigation patentable

Contributed by Klinkert Zindel Partner

The Federal Supreme Court recently considered an application to patent a method of image-guided navigation for catheters inserted into pathologic sections of a human or animal antrums. Section 2a, Paragraph 1(2), Clause 1 of the Patent Act excludes methods for the surgical treatment of the human or animal body from patentability. The Patent Office and the Federal Patent Court had rejected the application in accordance with this clause, holding that the method under consideration related to a surgical treatment of the human or animal body. The Federal Supreme Court did not share this view and on August 31 2010 referred the case back to the Federal Patent Court for re-evaluation.

The Federal Supreme Court held that the law does not provide that all linguistic elements of a claim constitute features of the claimed invention. For example, product claims may include information relating to the purpose, effect or function of the product which are suitable to contribute to and limit the scope of the invention only under very specific circumstances (eg, if it is mandatory for the invention that the product is suitable for a specific purpose). In general, the product is independent from the purpose for which it is to be used according to the patent claim. Products are defined by spatial and physical features. According to the court, the same applies for process claims. It is generally permissible to include information in the patent claim that provides a person who is skilled in the art with instructions on how to interpret the scope of the invention. In the case before it, the court held that the navigation of the catheter into a pathologic section of the human or animal body did not constitute part of the technical teachings of the patent. The essential reason for the decision was that the patent application – as well as the claims – clearly distinguished between the imaging process and the catheter navigation; that is, the catheter navigation was not a constitutive feature of the invention. The court further held that the imaging process was not a diagnostic method (which is not patentable according to Article 54, Paragraph 4 of the European Patent Convention and Section 2a, Paragraph 1(2), Clause 1 of the Patent Act), but merely an intermediate step in or auxiliary means of diagnostic process.

The decision shows that many inventions in the field of diagnostic or surgical equipment may be patentable, despite the non-patentability statutes of the Patent Act and the European Patent Convention. However, the devil is in the detail and it is crucial to keep in mind the prerequisites established by the Federal Supreme Court – namely, that references to surgical or diagnostic methods must be clearly distinguishable from the invention itself.

For further information on this topic please contact
Philipp Ess at Klinkert Zindel Partner by telephone (+49 69 972 65 600), fax (+49 69 972 65 6099) or email (


(1) File X ZB 9/09.