The patent claims cover rivaroxabine in the form of rapid-release tablets and only one feature regarding the use of this substance: once a day.

Courts in Europe resolve the issue of patent validity inconsistently, although without surprise. In the United Kingdom, on 24 May 2024, the Court of Appeal upheld the decision to invalidate the patent; in Germany, the court issued a preliminary opinion on recognising the validity of the patent. Seven patent invalidation proceedings are pending before the Patent Office of the Republic of Poland (UPRP).

Four decisions have been taken in a patent infringement case in Poland so far. In one case, the preliminary injunction was granted first, but its enforcement was nevertheless subsequently suspended by the court itself. In three other cases, the judges of the intellectual property court decided to dismiss the request for security.

In articulating the reasons for the decision, Judge Krzysztof Kurosz indicated that there was a high probability (more than 50%) that the patent would be invalidated due to the lack of technical features of the solution and the lack of an inventive level and sufficient disclosure of the invention. The court's conviction that the patent was likely to be invalidated was essential for the applicability of the relevant provisions of the Code of Civil Procedure (kpc) amended in 2023; they now requires courts to take into account the risk of patent invalidation when considering the grant of preliminary injunctions.

In the case concerned, the decision actually determines the balance of power in the market. A year and a half remains until the disputed patent expires and it is doubtful whether the patent invalidation case, on which the outcome of the infringement dispute depends, can be resolved during that time.

The IP court's line of jurisprudence in the rivaroraxabine dispute and the reasoning in the individual justifications indicate a strong tendency of the court to avoid the grant of preliminary injunctions in the case of rights of questionable quality. This is an important aspect in strategic decision-making by both parties of the pharmaceutical sector.

The issue of preliminary injunctions in the case of weak patents, with a relatively short shelf life, under the amended Code of Civil Procedure will certainly be the industry's focus in upcoming disputes.

Author: Żaneta Zemła-Pacud