GERMANY TRENDS AND DEVELOPMENTS Contributed by: Dr. Peter Klusmann, Gregor König, Dr. Dirk Schüßler-Langeheine and Dr. Lasse Christian Weinmann, Hoffmann Eitle
IFA’s Responsibility for Listing Pharmaceutical Products in their Databases In recent years, it has become common practice in Germany for patent holders to enforce pat - ents not only against the pharmaceutical com - panies responsible for manufacturing, offering and launching an infringing generic product on the German market but also against IFA GmbH. IFA is an information service provider for the pharmaceutical market, collecting information from pharmaceutical companies and process - ing it into databases, which are essential for marketing pharmaceutical products in Germany. Among others, the Lauer-Taxe relies on informa - tion provided by IFA. For a long time, case law in Germany has established that the inclusion of an infringing product in the Lauer-Taxe qualifies as an infringing offer by the pharmaceutical com - pany having applied for the product to be listed. There have been numerous disputes, however, to what extent IFA can be held responsible for (contributing to) patent infringement by including infringing products in their databases. There has been case law holding IFA responsible for check - ing whether any products listed in their databas - es were infringing and preventing the inclusion of such infringing products in their databases when they had a reason for a corresponding check. IFA would be required to exclude an infringing product from their databases upon receipt of a corresponding provisional injunction against the supplier of the relevant drug or upon receipt of a notification by the patentee informing IFA about the (threat of) infringement. In many cases, the infringement would be obvious, for example, if there is compound patent protection and it is clear to IFA already from the active pharmaceu - tical ingredient that the attacked product falls within the scope of patent protection.
ering almost the same subject matter against the same defendant. The authorities have recently become more willing to intervene if they perceive a misuse of the option to obtain and rely on multiple pat - ents of the same patent family protecting the same product. Following a dispute on patents covering the MS drug Copaxone (API glatiramer acetate), the European Commission (EC) issued a fine exceeding EUR460 million against Teva in October 2024 for abuse of its dominant market position (Article 102 TFEU). Teva was found to have created and enforced a “web of secondary patents” with similar content, which it strategi - cally withdrew “to avoid a formal invalidity ruling, which would have set a precedent threatening other divisional patents to fall like dominos”. According to the EC, Teva thereby artificially prolonged legal uncertainty on the validity of its patents, potentially hindering the entry of competition (EC, Press Release re AT.40588). As early as 2020, the Regional Court of Munich issued a first-of-its-kind injunction, preventing the patentee from dropping a patent that had been enforced to prevent a (negative) decision on such patent’s validity (7 O 1456/20). While the facts underlying the Copaxone inves - tigation are specific and also involved com - mercial activities of Teva “disparaging” their competitors, which were not patent-related, the EC’s decision is of high relevance for the filing and enforcement strategies of patentees with a dominant position on their respective (pharma) market when relying on divisional applications and patents deriving therefrom with largely over - lapping scope of protection.
109 CHAMBERS.COM
Powered by FlippingBook