Life Sciences and Pharma IP Litigation 2025

GERMANY LAW AND PRACTICE Contributed by: Dr. Clemens Tobias Steins, Dr. Michael Pfeifer, Dr. Daniel Grohs and Dr. Bianca-Lucia Vos, Hoffmann Eitle

• written guidance orders. In patent infringement proceedings, all of those are rather uncommon as of late. Eventually, the court will schedule the main hear - ing, usually about nine to 12 months after ser - vice. If the court deems it necessary, it can call wit - nesses proposed by a party to be present at the hearing for questioning, predominantly by the court. This is, however, also rare in patent infringement proceedings. To prepare for the hearing, the reporting judge writes a preliminary opinion based on the writ - ten submissions. This opinion is then discussed internally with the presiding judge and the third judge, resulting in the court’s preliminary opin - ion. At the outset of the hearing, the presiding judge presents this preliminary opinion to the parties involved. The attorneys then have an opportunity to respond to the court’s preliminary opinion. The entire hearing typically lasts about two to three hours. Upon the hearing, unless the court finds that their decision hinges on a factual issue on which evidence must be taken, the court will issue a judgment within typically four to six weeks. If the decision favours the plaintiff, the plaintiff can provisionally enforce the judgment upon provid - ing security. First-instance Nullity Actions As with infringement actions, the plaintiff initiates the action by filing a complaint with the Federal Patent Court ( Bundespatentgericht ) and paying the court fee. The complaint must set out all validity attacks in sufficient detail for the court

to decide on this basis alone, should the defend - ant not dispute it. A nullity action can be served on either the pro - prietor or the representative, as recorded in the GPTO patent register. With service, the court will set the defendant a one-month deadline to declare whether they intend to object to the request for invalidation and a deadline of a further month (extendable to two months if sufficient grounds are given) to substantiate the grounds for the objection. Within six months from service, the court shall issue a preliminary opinion. The parties can exchange further briefs, and the court can set further deadlines to guide this pro - cess. The main hearing is typically scheduled about 18 to 24 months after service, and a judgment is issued, usually about two months later. Considering that the nullity action is usually pre - pared and filed as a reaction to being served an infringement action, ie, at least one or two months later, and the overall longer duration, the infringement court regularly decides on infringe - ment, and a potential stay, before the nullity court has heard the case. The above-mentioned (early) preliminary opinion has been introduced to assist the infringement court in deciding whether to stay. 1.6 Requirements to Bring Infringement Action While an infringement action can be filed before a patent grant, a cease-and-desist order (in main or provisional injunction proceedings) requires that the mention of the grant has been published.

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