INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP
Italy The most significant development in Italian pat- ent litigation in 2024 was the Italian Supreme Court decision issued on 5 July 2024, No 18372, on the scope of the Bolar exemption under Article 68(b) of the Italian Intellectual Property Code (IPC). It is believed to be the first Supreme Court decision in Europe to have interpreted the exemption. The Court found that the Bolar exemption applies not only to generic com- panies engaged in studies directed at obtain- ing a marketing authorisation (MA), but also to third-party manufacturers of patented active pharmaceutical ingredients (APIs) that supply the drug to those who intend to obtain an MA. However, in relation to third-party suppliers, the Court established that the rationale of the Bolar exemption is complied with only if: • the fact that the API manufacture is directed at obtaining an MA is clear from the start; • the generic company has requested the third- party supplier to provide the API; and • there are contractual limitations in place so that the use of the API is limited to obtaining the MA, in line with the Bolar exemption. In the absence of these conditions, the Bolar exemption cannot be invoked and, therefore, the activity will be considered infringing. Another interesting decision was issued by the Appeal Court of Milan (decision No 976, issued on 2 April 2024). The case concerned the deter- mination of the fair remuneration to be awarded to an employee pursuant to Article 64 of the IPC when the employer does not make use of the invention. As a general note, Article 64 of the IPC distinguishes between • remunerated inventions – the inventions developed by an employee in the course of
ity of AI-generated inventions. Specifically, in a decision involving the question whether an AI- system could be named as an inventor, the Fed- eral Court of Justice came out with a clear “no” (German Federal Court of Justice, X ZB 5/22). Another decision published in 2024 concerned the scope of the defendant’s obligation to pro- vide information to allow the patentee to calcu- late damages following a determination of pat- ent infringement. The Federal Court of Justice made it clear that the obligation included any commercial agreements the patent infringer had entered into in relation to the accused embodi- ment, including maintenance and repair agree- ments for patent infringing products, or sales of consumables, simply on the basis that there is a reasonable likelihood that these sales would not have been made without the patent infringe- ment. This decision makes it clear that what are often characterised as “convoy sales” must also be included in the damages calculation (Federal Court of Justice, X ZR30/21). In a further decision on patentability the Federal Court of Justice clarified that when several path- ways were available to solve a technical prob- lem, several pathways towards the invention may be obvious. There is no rule of law saying that only the “first” pathway is obvious (Federal Court of Justice X ZR 51/22). In the pharma space, patent enforcement cam- paigns are under scrutiny by competition law experts following the European Commission’s decision to issue a record fine of EUR462.6 mil- lion in a case concerning the enforcement of pharma patents, including in the German patent courts (Case AT.40588).
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