Pharmaceutical company Lundbeck held a European patent for escitalopram, the active substance of an antidepressant commercialised in Belgium under the trademark SIPRALEXA. The patent expired in 2009, but Lundbeck obtained a supplementary protection certificate (SPC) extending protection for escitalopram until June 1 2014. However, the SPC was invalidated by the Brussels Commercial Court following a nullity suit brought by several generic manufacturers. Lundbeck appealed that decision.
Pending the outcome of the appeal, another generic company, Eurogenerics, brought its generic version of escitalopram to market. Lundbeck started preliminary injunction proceedings against Eurogenerics based on the invalidated SPC. At first instance, Lundbeck's claim was rejected, but its appeal was successful and the Brussels Court of Appeal issued an injunction against Eurogenerics. According to this court, the Supreme Court decision of January 5 2012(1) – which held that the revocation of a patent by the European Patent Office's opposition division, against which an appeal had been lodged pursuant to Article 106(1) of the European Patent Convention, did not affect the prima facie validity of the Belgian counterpart of the revoked patent – was equally applicable to the present circumstances. The court held that the appeal of a nullity decision of a Belgian court has suspensive effect as well. Lundbeck's SPC was therefore found to retain its prima facie validity pending the outcome of the appeal against the first instance invalidation decision (in which the SPC was eventually upheld).(2)
Eurogenerics appealed to the Supreme Court, claiming that the annulment of the SPC by the first instance court had the authority of res judicata (ie, the fact that a case has already been decided) and should therefore have been respected by the court that issued the preliminary injunction.
The Supreme Court rejected Eurogenerics's reasoning and upheld the decision of the Brussels Court of Appeal on the following grounds:
- There is a difference between the authority of res judicata, which is attributed to every final court decision that has not been overruled, and the force of res judicata (ie, an unappealable decision). As long as the decision has no force of res judicata, the authority of res judicata is only conditional.
- According to the Belgian Patent Act, a decision by which a patent is invalidated normally has the authority of res judicata. However, such decisions are not recorded in the patent register before obtaining the force of res judicata.
- The Patent Act also states that an appeal to the Supreme Court has suspensive effect with respect to an invalidated patent.
- Finally, the Belgian Judicial Code states that an appeal normally suspends the enforceability of a decision.
The Supreme Court consequently held that a patent that was invalidated by a first instance decision can still be the basis for a subsequent preliminary injunction action.
In its January 5 2012 decision the Supreme Court held that the fact that a patent was revoked by the opposition division of the European Patent Office did not affect the prima facie validity of the revoked patent, as long as no final decision has been taken in the opposition proceedings, because according to Article 106(1) of the European Patent Office, an appeal against decisions of the opposition division has suspensive effect.
In the present case, the Supreme Court took this reasoning one step further and found that the prima facie validity of a patent (or SPC) is also not affected by an invalidity decision of a national court, notwithstanding the fact that this decision has the authority of res judicata. Consequently, a patent holder requesting a preliminary injunction against an alleged infringer can rely on the prima facie validity of its patent or SPC until the decision by which the patent was invalidated has obtained the force of res judicata – that is, once an appeal to the Supreme Court has been rejected or the limitation period for bringing the appeal has expired.