Under German law, neither the application for a marketing approval nor obtaining it constitutes a ‘use’ act under Section 9 German Patent Act. This provision only lists the manufacturing, offering, putting on the market, using and importing or owning the product for such purposes as relevant acts. The request for a marketing authorisation and its subsequent grant are simply administrative acts (cf. also Common Position (EC) No. 61/2003 (C 297/E/41) regarding Art. 10 para. 6 of Directive 2004/27/EC).
In addition, the competent authority may request the provision of samples during the authorisation proceedings. However, such use of the patented invention should be covered by Section 11 No. 2b German Patent Act (implementing Art. 10 para. 6 of Directive 2004/27/EC), which excludes from patent infringement studies and tests (and consequential practical requirements), which are necessary to obtain an approval.
It is expressly stated in the Common Position (EC) No. 61/2003 that the submission of a sample would have to be considered a “consequential practical requirement” (German legislative preparatory document uses a similar formulation, BT-Drs. 15/5656 of June 9, 2005, p. 15, 18).
Accordingly, the question arises whether seeking and receiving approval might constitute a threat of infringement, sufficient to justify preventive injunctive relief for future infringement.
In the light of Section 11 No. 2b German Patent Act it appears questionable to determine a threat of infringement by such acts as this provision is intended to facilitate the launch of generic pharmaceuticals immediately after patent expiration.
Furthermore, the mere application for marketing approval does not necessarily mean that the product will in fact be approved and put onto the market. In its decision of 29 March 2006, the Higher Regional Court of Düsseldorf stated that conducting the marketing authorisation procedure does not generally allow for the conclusion that the applicant will launch the product immediately after its grant (Mitt. 2006, p. 426 et seq.).
Even where a marketing authorisation has already been granted, it is not compulsory for the holder to actually market the product. According to the above decision, the mere possibility of a launch does not create an imminent threat of infringement. If the patent expired soon thereafter, it could well be that the marketing authorisation holder would simply await the patent’s expiry and launch the product on the market the subsequent day.
The Higher Regional Court of Düsseldorf did not even consider there to be an imminent threat of infringement despite the fact that the generic company had a strong economic interest in advertising the product in the “Lauer Taxe”, a German registry of approved drugs, shortly before patent expiry. This economic interest resulted from the fact that the next “Lauer Taxe” would have been published just two weeks later. The court came to the conclusion that only in case of generic company known to regularly launch its products before patent expiry, would there be a threat of infringement.
Therefore, there are potentially circumstances in which a threat of infringement may appear imminent (and thereby justifying injunctive relief for future infringement) but there has to be some indication that the holder of the marketing authorisation intends to launch the product before patent expiry.
A further noteworthy decision of the Federal Supreme Court considers where German courts should draw the line between preparatory acts excluded from patent infringement and acts that do infringe such as the offering of a product. In the “Simvastatin” case (BGH XZR 76/05 of 5 December 2006, GRUR 2007, p. 221 et seq.) the Federal Supreme Court held that advertising a product in the “Lauer-Taxe” before expiration of a supplementary protection certificate would constitute an infringing act even though it was expressly mentioned that the product would only be available after patent expiry.