Court of Appeal of Düsseldorf, Decision of 19 October 2012, No. 4b O 135/12

(At least) since the "Harnkatheterset" ("Urinary Catheter Set") decision of the Court of Appeal of Düsseldorf[1], the grant of a preliminary injunction in patent matters was considered to require that the patent in question had already "survived" opposition or nullity proceedings. Still, there are exceptions to that rule. This catalogue of exceptions was now further specified by the Court of Appeal of Düsseldorf for the case of early generic market entry.

Under German (case) law, the requirements to obtain a preliminary injunction in patent infringement cases are very strict. In principle, a preliminary injunction is only granted if both the question of patent infringement and the validity of the patent can be "answered in favor of the applicant so unambiguously that it is clearly unlikely that an incorrect decision is made which would have to be revised in subsequent main proceedings."[2] In particular, the validity of the patent in question must be "sufficiently safe."[3]

Basically, a patent's validity is only considered as "sufficiently safe" for the purposes of preliminary injunction proceedings, if it has already "survived" opposition or nullity proceedings. However, exceptions to this rule can be made, especially where extraordinary circumstances make it unacceptable for the patent holder to wait for the outcome of the main proceedings.

In the case at issue, the patent application was filed in October 1992 and the patent was granted in September 1997. Since 1996, the claimant had been marketing an "original" medicament protected by the patent.

The defendants obtained marketing approvals for their generic drugs in July 2009. As of mid-2012, they offered these products for sale by listing them in the so-called "Lauer-Taxe".[4] Only then, i.e. nearly at the same time of the product launch and only months before the expiry of the patent, the defendants filed a nullity action with the Federal Patent Court.

The Court of Appeal of Düsseldorf stated that in such a situation, the grant of a preliminary injunction did not require that the patent's validity has been confirmed in opposition or nullity proceedings. The defendants had sufficient time to initiate nullity proceedings in order to assess the patent's validity before entering the market. The fact that the marketing authorizations were already obtained in July 2009 allowed for the conclusion that the market entry was based on long-term planning. Even if the decision on the actual commercialization was made at a later point, the defendants had to attack the patent immediately after that. However, the defendants only filed the nullity action hesitantly and at the same time of the market entry. Under these circumstances, the court found that the threshold for deciding whether a patent was "sufficiently valid" for the purposes of preliminary injunction proceedings was "evidence of invalidity".

The court also considered that the patent expired within a few months after the generic market entry. Consequently, it was not possible for the patent holder to obtain a decision on validity before the expiry of the patent. In addition, the defendants were only restrained from marketing their products for this short period of time. After all, on the basis of a balance of interests, the decision had to be made in favor of the claimants.

This case shows that it is not only up to the claimants in preliminary injunction proceedings to enforce their rights in a timely, non-hesitant manner. Rather, a hesitant conduct of procedure can also harm the position of the defendant, in particular when it comes to the timing of a nullity action. The strategy to enter the market with a generic product shortly before the expiry of an "untested" patent – which has apparently been pursued by individual generic companies – will probably be less successful in the future. In the meantime, this case law has been confirmed by Court of Appeal of Düsseldorf in several other cases.