On 24 February 2014, the German Federal Court of Justice (Bundesgerichtshof, ‘FCJ’) handed down its decisions Kollagenase I and Kollagenase II (ile numbers X ZB 5/13 and X ZB 6/13) on the patentability of second or further medical use claims specifying the term ‘speciic use’ under Article 54(5) EPC and Section 3(4) German Patent Code (PatG) respectively.

The decisions of the FCJ clarify the interpretation of the term ‘speciic use’, and set a precedent for the patentability of second medical uses in Germany. The decisions are of great interest to the pharmaceutical industry, as they open up new opportunities for patent protection following the expiry of a composition of matter patent.

The factual background of the decisions

The FCJ was asked to rule on the validity of patents claiming the use of collagenase for the treatment of Dupuytren disease and Peyronie disease. The use of collagenase to treat these two diseases was already known and the only feature of the patents in question not known from the prior art was the instruction that the treated body parts should be kept immobilised for several hours following the injection of the substance.

The findings of the court

The FCJ has held that patentability is not excluded even if a dosage instruction is the only feature of a patent which is not found in the prior art. Furthermore, patentability is also not precluded where instructions contained in the patent claims relate not to the dosage but to other modalities of the use claimed by the patent.

The FCJ reasons that the ‘specific use’ requirement within the meaning of Article 54(5) EPC, and the wording of Section 3 PatG respectively, does not require the treatment of a different disease. In fact, the court considered that, in addition to the dosage and the target indication, other aspects such as the method of administration, the consistency of the substance or the specific patient population, are also of importance for assessing the specific use.

Moreover, the FCJ continues to consider that, according to Section 2a(1)(no.2) PatG and Article 53(c) EPC, aspects of the claimed use which do not relate to substance properties and the effect of the substance on the human body must not be considered when assessing patentability. Therefore, according to the FCJ, in order for treatment instructions to contribute to patentability, these instructions must objectively aim to enable, strengthen, catalyse or otherwise improve the effect of the substance, provided that these instructions do not relate to therapeutic methods suitable for treating the disease in question, the effects of which are additional to and independent of the substance itself.

The FCJ referred both cases back to the German Federal Patent Court (Bundespatentgericht, BPatG) and considered the indings of the BPatG insuficient to deny patentability of the patents in question. The BPatG therefore has to reassess the cases in the light of these rulings.