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2010 12. 09.

German Patent Law

BGH Decision "Image support for catheter navigation" regarding Patentability of Surgical, Therapeutic and Diagnostic Methods

The German Federal Court of Justice (Bundesgerichtshof, BGH) has recently issued the decision X ZB 9/09 – "Image support for catheter navigation" (Bildunterstützung bei Katheternavigation) regarding the patentability of surgical, therapeutic and diagnostic methods under German law.

In this decision, the BGH held that a method for image support of the targeted navigation of a catheter invasively inserted into a cavity of an organ of a human or animal body does not fall within the exclusion of methods for treatment of the human or animal body by surgery. Specifically, the BGH decided that the exclusion of methods for the treatment of the human or animal body according to Section 2a German Patent Act does not include the patenting of methods that can be used in connection with the performance of a surgical method. In this respect, the Federal Court of Justice explicitly referred to the decision of the Enlarged Board of Appeal of the EPO G 1/07 dated February 15, 2010 (particularly to point 5 of the reasons of the decision of the Enlarged Board of Appeal).

The Federal Court of Justice also addressed the issue of the exclusion of diagnostic methods from patentability (refer to points 22 and 23 of the reasons of the decision). In this reasoning, the Federal Court of Justice explicitly followed the approach taken by the Enlarged Board of Appeal of the EPO in decision G 1/04, dated December 16, 2005, according to which it is accepted that the method steps to be carried out when making a diagnosis as part of the medical treatment of humans or the veterinary treatment of animals for curative purposes (excluded from patentability under Section 2a German Patent Act or Art. 53 c) EPC2000) include:

(i) the examination phase involving the collection of data (examination phase),
(ii) the comparison of these data with standard values (data comparison),
(iii) the finding of any significant deviation, i.e. a symptom, during the comparison (deviation determination phase), and
(iv) the attribution of the deviation to a particular clinical picture, i.e. the deductive medical or veterinary decision phase (decision phase).

In the decided case, the claimed method was regarded as not falling within the exclusion from patentability with regard to diagnostic methods, since the claimed method was regarded as only an intermediary method for the determination of a disease, which per se does not justify the exclusion from patentability.

Download the full text of the decision decision X ZB 9/09 – "Image support for catheter navigation" (Bildunterstützung bei Katheternavigation) of the German Federal Court of Justice under:

http://www.mueller-bore.de/tl_files/Decisions_BGH/Bildunterstuetzung_bei_Katheternavigation.pdf

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