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LIFE SCIENCES IN GERMANY


LSIPR: When should a life sciences company bring validity proceedings before the Federal Patent Court?


TF: Validity proceedings should be brought whenever possible, as long as there is no opposition pending. A plaintiff should always bring a validity complaint because there is always a chance that the Federal Patent Court will, for example, find the subject matter of a patent not inventive, not novel, or perhaps it cannot be carried out without undue burden, and so forth. Te Federal Patent Court is not bound by a previous European Patent Office (EPO) decision and can therefore invalidate a patent which was maintained by the EPO on opposition. Tis can even happen on the basis of the same prior art documents. Although there is a trend of harmonising German case law with EPO case law, there are still differences. For example, an invention related to a second medical use based on a different dosage regime which is considered to be patentable by the EPO is invalid under German case law. Unless the validity of a patent is set in stone, then our advice is to always bring a complaint so the validity of the patent can be refuted.


LSIPR: Have there been any changes to Federal Patent Court proceedings that life sciences companies need to be aware of?


TF: Tere was a major change, effective from October 1, 2009, that affects all companies involved in litigation in German courts. A de novo trial on appeal has been changed to a limited review on appeal. Tat is limited in the sense that new facts, new claim versions and new requests cannot be submitted at will. It will become important to provide a full pleading of the case, possibly including party experts in the first instance.


LSIPR: How do validity proceedings work and how can they affect parallel infringement actions?


TF: Te validity proceedings are started by filing a invalidity action with the Federal Patent Court in Munich. If the patentee defends the patent, the Federal Patent Court issues a preliminary opinion similar to the EPO in opposition proceedings. Te patent court will take no longer than a day to make a decision on the validity. Te losing party can then file an appeal to the Federal Supreme Court.


In principle, the validity and infringement


proceedings have no connection. Te connection is made by the possibility of the defendant in an infringement case requesting a stay of the procedure until validity is decided. Te defendant’s argument would be that the court can either wait until infringement is found or wait until the validity of the patent has been confirmed, otherwise one will negate the other. Te infringement court’s standard for granting a stay request is an ‘overwhelming likelihood’ that the patent will be revoked or declared invalid in the validity proceedings. Tat standard is pretty high and is not easy for the defendant to show.


LSIPR: What are utility models and how useful are they as tools in life sciences patent litigation?


JH: A German utility model gives the owner the same rights as a patent does, in principle. Tey protect product claims rather than process or method claims. A utility model also has a shorter lifespan than a patent—it lasts for a maximum of 10 years instead of 20. Utility models are not available for gene-related inventions. Tey may be important litigation tools for pharmaceuticals, diagnostics or medical devices. Even second


20 Life Sciences Intellectual Property Review 2011


www.worldipreview.com


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