GERMANY LAW AND PRACTICE Contributed by: Dr. Clemens Tobias Steins, Dr. Michael Pfeifer, Dr. Daniel Grohs and Dr. Bianca-Lucia Vos, Hoffmann Eitle
4.3 Paediatric-Use Marketing Authorisations
5.2 Final Injunctive Relief A first-instance judgment in favour of the plaintiff may include an order to cease and desist from undertaking certain specified activities (final injunctive relief) as well as further claims of relief, such as the recall and destruction of infringing products. The enforcement of a first-instance judgment that is not (yet) final requires the plaintiff to pro - vide security (often in the form of a bank guaran - tee) for the defendant for the damages incurred due to the enforcement, should the judgment be set aside upon an appeal. The amount of secu - rity is within the court’s discretion but is usually set at the same level as the value in dispute on which the court fees and reimbursement claims are based (see 5.5 Legal Costs below). To enforce the cease-and-desist order, the plain - tiff must indicate to the defendant that the judg - ment is enforced by serving a copy of the judg - ment and the aforementioned security. The defendant can petition the appeal court to stay the enforcement, but this is granted only in exceptional cases. 5.3 Discretion to Award Injunctive Relief (Final or Preliminary) German law provides for an action for a compul - sory licence, which can be filed with the Federal Patent Court. To prevail in this action, the appli - cant must demonstrate that: • they have unsuccessfully tried to obtain a use right from the proprietor on reasonable terms; and • the public interest calls for the grant of a compulsory licence.
Special MAs are possible for the paediatric use of a medicine that already has an MA for adults. These medicines must no longer be covered under a patent or an SPC and, furthermore, may not be developed specifically for children. As mentioned (see 4.2 Paediatric Extensions above), the paediatric use has to follow the PIP. With a paediatric-use MA (PUMA), data protec - tion is established for eight years and two sub - sequent years of market exclusivity. This topic is governed by Regulation (EC) No 1901/2006. 4.4 Orphan Medicines Extensions For the time being, an extension of the SPC term is not available for orphan drugs. However, an orphan drug has the advantage of a ten-year orphan exclusivity (see Article 8 of Regulation No 141/2000). This period can be extended by up to two additional years if clinical studies in accordance with an agreed PIP are completed. There are plans to reform the EU pharmaceutical legislation, which are likely to result in changes in the regulatory exclusivity periods.
5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief
Instead of a preliminary injunction in main pro - ceedings, German law provides for a right to commence provisional injunction proceedings separately from main proceedings. We have addressed the relief available in those proceed - ings under 1.3 Preliminary Injunction Proceed- ings above.
99
CHAMBERS.COM
Powered by FlippingBook