Which criteria does the UPC apply with regard to the validity of the patent when a preliminary injunction is requested?

One of the questions at the opening of the UPC was which criteria the new court will apply for granting preliminary injunctions when the validity of the patent in suit is attacked by the defendant.

The Rules of Procedure are rather short in this regard and say in R.211(2)

“ In taking its decision the Court may require the applicant to provide reasonable evidence to satisfy the Court with a sufficient degree of certainty that the applicant is entitled to commence proceedings pursuant to Article 47, that the patent in question is valid and that his right is being infringed, or that such infringement is imminent.” (Highlights added by the author)

One might recall in this regard that the CJEU in its decision Phoenix vs. Harting of April 22, 2022, Case C-44/21 said in para. 41 that “European patents enjoy a presumption of validity from the date of publication of their grant”. It would therefore been arguable that the UPC could apply a rather low standard in a way that validity is generally presumed based on the fact that the patent was granted.

With the first preliminary injunction cases decided, the fog clears slightly and some general principles shine through:

In a trade fair case, the LD Düsseldorf (decision of June 22, 2023, UPC_CFI_177/2023, myStromer/Revolt Zycling) assumed validity because the patent in suit was granted in 2015 and not attacked since then. Also, the defendant in this case had not presented any invalidity attacks in the protective letter in response to a prior warning letter.

The Court of Appeal (decision of February 26, 2024, UPC: CoA_335/2023, 10xGenomics/Nanostring) found that it must be convinced with a sufficient degree of certainty that the patent is valid. Sufficient degree of certainty is lacking if the court considered it more likely than not that the patent is not valid. The burden of presentation and proof lies with the defendant in that regard.

The LD Düsseldorf (order of December 11, 2023, UPC_CFI_452/2023, Ortovox/Mammut, german) found in an ex parte order that there is no requirement that the patent must have survived two-sided validity proceedings to be sufficiently “secure” to be basis of a preliminary injunction. Rather, in this case, the anticipated invalidity attacks that emanated from a nullity action by one of the defendants against the Swiss part of the European patent did not raise reasonable doubt with the court. On April 4, 2024, the same LD confirmed that the fact that a patent was battle-tested in two-sided national validity proceedings or opposition proceedings before the EPO is a strong indication for the validity of the patent. However, it is not a requirement for summary proceedings. Another important indication is given if the validity of a patent has not been challenged for several years after its grant.

The LD Hamburg in its decision of June 26, 2024 (UPC_CFI_124/2024, Amgen vs. Alexion) carefully weighed up the criteria that are necessary to consider a patent as sufficiently secure basis for granting a preliminary injunction: It found that the defendant bears the burden of presentation and proof for the lack of validity of the patent. In any case, invalidity arguments could only be considered if the patent is indeed under attack, be it EPO opposition proceedings or a national or UPC revocation action. The UPC has to form its own view on the validity of a patent based on the principles of the EPC. Because it can only undertake a summary assessment in preliminary injunction proceedings, it has in the event of an EPO opposition to additionally consider whether there is a sufficient likelihood that the EPO will revoke the patent. The LD Hamburg in this decision also dealt with the frequent constellation that the third party observations had been filed during prosecution. In the present case, the third party observation mostly dealt with formal aspects of the original patent application but not with the arguments that had been central to the defendants’ case. The LD Hamburg made it very clear that it can therefore not blindly follow the grant decision.

From these decisions, the following conclusions can be drawn:

• The burden of presentation and proof for the invalidity of the patent in suit lies with the defendant,
• The fact that the patent was granted is per se not sufficient for a grant of a PI provided that the patent is attacked in invalidity proceedings (opposition or revocation),
• The UPC has to form its own view on the validity of a patent based on the principle of the EPC, because it can only undertake a summary assessment in preliminary injunction proceedings, it has, in a second step, additionally to consider whether – e.g. in the event of a parallel opposition – there is sufficient likelihood that the EPO will revoke the patent.
• The fact that a patent being battle-tested in two-sided national validity proceedings or opposition proceedings before the EPO is a strong indication for the validity of the patent, but not a requirement for summary proceedings, and that another important indication is given if the validity of a patent has not been challenged for several years after its grant. • Third party observations during prosecution do not automatically mean that the patent is considered to be “battle-tested”. Third party observations only lead to a sufficient security of the patent if the TPOs indeed dealt with the arguments brought forward by the defendant.