Facts
Company A. Company, the holder of European patent EP x, filed a patent application for pharmaceutical formulations containing the active ingredients oxycodone and naloxone for the treatment of pain and reduction of side effects. The patent was granted on 10 May 2017. Company B. AG brought an action for nullity of the patent before the Federal Court, arguing that the subject-matter of the patent went beyond the content of the initial application.
The patent application was based on an international patent application WO y, filed on 4 April 2003, and on two German patent applications, DE v and DE w, filed on 5 April 2002. Claim 1 of the international patent application was formulated in a broad manner, whereas Claim 1 of patent EP x was modified to include specific details on pharmaceutical formulations.
The Federal Court examined the question of whether the modifications made to the patent application during the filing procedure were admissible under Article 123(2) EPC, which limits the modifications that can be made to a patent application.
Considerations
Article 123(2) EPC only allows the modification of a patent application within the limits of what the skilled person is objectively able to directly and unambiguously deduce from the entire documents as they were initially filed. The Federal Court examined the criteria for assessing the admissibility of the deletion of elements from lists comprising several modes of implementation or alternative characteristics.
The Court considered that the deletion of certain elements from the list of pharmaceutical formulations and the selection of a single specific formulation constituted an inadmissible modification, as it created a new product that was not foreseen in the initial application. The Court also considered that the…