Therapy-related instructions (“therapiebezogene Anweisungen”) may contribute to patentability if they objectively aim at allowing, enhancing, accelerating or improving otherwise the effect of a substance. Aspects not relating to the characteristics of the substance and its effect on the human or animal body are, however, to be disregarded pursuant to Section 2a (1) No 2 German Patent Act and Article 53 (c) European Patent Convention.
The cases at issue both relate to appeal proceedings before the German Federal Supreme Court that had to decide whether the Federal Patent Court was right in rejecting two German patent applications, DE 198 13 748.6 and DE 100 27 521.4, respectively. Both applications are directed to the enzyme collagenase for use in the treatment of particular, abnormal fasciae made of collagen bundles that lead to distortions of different parts of the body. The collagenase, a protease, is injected into the relevant collagen bundle, where it degrades the collagen and thus provides relief from the medical condition. The use of collagenase for such treatment was known from the prior art. The claims at issue are phrased as further medical use claims according to Section 3 (4) German Patent Act and Article 54 (5) European Patent Convention (EPC) and relate to a relatively high dosage of collagenase for injection into a collagen bundle followed by an immobilization of the relevant part of the body for several hours in order to avoid spreading of the collagenase from the site of injection. Spreading would cause a reduced therapeutic effect of the collagenase in the collagen bundle. The Federal Patent Court had rejected the applications based, inter alia, on the finding that despite its allowable wording as a further medical use, the immobilization step following the injection would not characterize the collagenase or its formulation to be injected and that the feature would be nothing but an instruction to the physician in charge. Thus, the feature would be excluded from patentability pursuant to Section 2a (1) No 2 German Patent Act and Article 53 (c) EPC and consequently to be disregarded for the assessment of patentability of the claimed subject-matter.
In this respect, the Federal Supreme Court set aside the Federal Patent Court’s ruling based on the following considerations: The measure of immobilizing the relevant part of the body serves the purpose of improving the effect of the administered collagenase. The measure is not an additional one for treating the disease that is independent from the effect of the substance. Consequently, this feature is not excluded from patentability. Both cases were remitted to the Federal Patent Court to determine whether the feature to immobilize the respectively treated part of the body after collagenase injection confers not only novelty to the claimed subject-matter but also involves an inventive step over the prior art, including the standard repertoire of a physician at the priority date.
In its decisions, the Federal Supreme Court emphasizes that the European and the German provisions with respect to further medical use claims are considered to be applied identical by both, the European Patent Office and the German authorities. In its decision, the Federal Supreme Court also refers to EPO case law, in this respect, such as G 2/08. A restriction, e.g. to the dosage of a substance, cannot be derived from the further medical use provisions. Consequently, different kinds of administration (such as orally, transdermal or different kinds of injections), the consistency of the substance (such as solid, liquid or gaseous), the patient group or any other parameter that has an influence on the effect of the substance constitute a patent eligible specific use of the substance. Now, the Federal Supreme Court made clear that also therapy-related instructions may well meet this requirement.