Germany: No imminent threat of patent infringement upon obtaining a marketing authorisation

18 December 2012

Beate Methner

Recently, the Higher Regional Court Dusseldorf decided the requirements needed to grant preliminary injunction in Germany under the danger of first infringement.

The plaintiff, a pharmaceutical company, had motioned for a preliminary injunction at the Regional Court Dusseldorf against a generic manufacturer in February 2012. It was applied for on the basis of a substance patent and respective supplementary protection certificate (SPC). At this point in time, the infringing embodiments had neither been marketed nor had it been announced they were launch in Germany. The plaintiff based its application for preliminary injunction primarily upon the fact that the defendant had obtained a central marketing authorization (MA) for the products at issue nearly two years before the patent was to expire.

The Regional Court in a judgment dated 12 April 2012 dismissed the plaintiff’s motion and denied the grant of a preliminary injunction. Following an appeal filed by the plaintiff, the Higher Regional Court Dusseldorf confirmed the decision and again dismissed the preliminary injunction request on 20 September 2012. 

The patent and SPC at issue were directed at a virostatic agent for the treatment of HIV and AIDS. The central MA obtained by the defendants was a generic MA based on the originator’s central MA for the respective product. The SPC was due to expire on 20 November 2013. The plaintiff alleged that there was a danger of first infringement on the basis of the generic MA, which was obtained quite some time in advance of the patent expiry date, and the defendant allegedly failing to (sufficiently) respond to warning letters sent to him after the plaintiff had become aware of the MA. In particular, the defendant refused to issue a cease and desist declaration or give an undertaking to notify the plaintiff eight weeks in advance of any launch of the product at issue, both demanded by the plaintiff. The plaintiff argued that, particularly in the light of the Enforcement Directive, it was entitled to the preliminary injunction it sought.

The Regional Court Dusseldorf found that a danger of first infringement was not at hand. In its judgement it first summarized the legal standard, stating that for a danger of first infringement there needed to be concrete facts which tangibly showed that there was an imminent threat of infringement. The mere possibility of infringement was held not to be sufficient. Rather, the presence of circumstances which allowed for the conclusion that the alleged infringer had already decided to commit the infringement so that it was solely in his hands whether an infringement occurred or not, were required. On this basis the Regional Court Dusseldorf found that the facts at hand neither individually nor in combination allowed for the conclusion that a launch by the defendant was imminent.

In particular the fact that the MA was obtained 22 months prior to the patent expiry date did not justify a finding of a danger of first infringement. The MA would in any event not expire for another three years pursuant to the so-called “sunset clause” of Art. 14 (4) of Regulation (EC) No 726/2004. Therefore, the defendants may have only prepared the launch for day one after the expiry of the SPC. With regard to the alleged failure to respond to warning letters, the court held that since there had not been a danger of first infringement, the defendant was under no obligation to issue the requested declarations.

The court went further to say the defendant had conceivable reasons to refrain from doing so voluntarily as the plaintiff had shown, in the course of the proceedings, that it was prepared to use such declarations against the defendant. The court also stated that the Enforcement Directive did not require a different standard as to the requirements for a danger of first infringement since the available remedies were sufficient.

Subsequently, the Higher Regional Court Dusseldorf has confirmed this decision on appeal. The Court based its decision on the legal standard as set out above. The Senate in particular emphasized that obtaining an MA, well in advance of the expiry date of the respective protective right, did not allow for the assumption of an early market and thus danger of first infringement.

The Court took into account the ratio of the Roche-Bolar-Rule, as well as the Sunset-Clause, concluding that the obtaining of an MA was not a risk of launch at hand, but rather a preparatory act for a launch immediately after expiration of the protective rights at issue. This was enhanced by the fact the defendant had undisputedly submitted that the MA procedures may vary greatly in length therefore MAs were usually applied for well in advance to ensure that these are, in any event, granted in time.

The Senate also rejected the plaintiff’s argument that a different standard should be applied. It was argued that it was not essential that the launch was imminent merely a sufficient probability that the launch would occur before expiration of the relevant protective rights.
   
The Court stated that the requirement for an infringement to be imminent was indeed justified. The justification being that legal remedies were not necessary for a tangible infringement at some point in the future with which the relevant circumstances might still change.

In any event, the plaintiff would need to show circumstances which allowed for the conclusion that an act of infringement was threatening during the protection period of the protective rights. The court found that the plaintiff had failed to do so and that the Enforcement Directive did not call for a different standard either. The Court particularly emphasized that in the context of legal relations, silence was generally neutral. Only if there was an obligation to issue a declaration, silence by one of the parties could be of significance. However, the Court continued that there was no general principle that the addressee of a warning letter was under an obligation to issue a cease and desist declaration in order to avoid the establishment of a danger of first infringement. Therefore the plaintiff had no reason to assume - due to the silence by the defendants as to the warning letters - that a launch by the defendant before expiry of the protective rights would occur requiring judicial remedies to prevent it.

According to the Court, contrary to the plaintiff’s view, the alleged peculiarities of the pharmaceutical industry did not justify a different assessment either. On the contrary the Court found that the market for pharmaceutical products was especially transparent (e.g. to the listings in pharmaceutical databases), as submitted by the defendant, and thus easy to monitor. The Court also stated that the early launch of a different product abroad did not give any indication as to the defendant’s intention for the infringing embodiments on the German market due to the territorial scope of national patent law.

In summary, the Higher Regional Court Dusseldorf has confirmed the requirements needed to grant a preliminary injunction in Germany under the danger of first infringement. It particularly emphasized that the grant of a MA was not sufficient and that there was no general obligation for the MA holder to respond to respective warning letters.

The patent proprietor had also applied for preliminary injunctions in the UK and the Netherlands. The motion in the Netherlands related to all designated contracting states except for Germany and the UK. In the UK, the preliminary injunction was granted at first instance on the basis that the MA was obtained well in advance of the expiration of the protective rights. In the Netherlands, the case was dismissed for the same reasons as above.

This article was written by:



Beate Methner
Associate
beate.methner@twobirds.com

Other articles in the Life Sciences newletter for December 2012:

> Pan-European declaration of non-infringement can be brought before the English Courts

> Czech Republic: New restrictions on advertising of pharmaceuticals

> Spain: Supreme Court ruling on reference pricing system

> CJEU dismisses appeals by AstraZeneca and upholds General Court Judgement

> Dutch reference to the CJEU: Georgetown University v Dutch Patent Office