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The Court of Appeal of the UPC overturns a preliminary injunction.

Legal battle between multinational companies in the biotech industry: one of the first rulings of the Court of Appeal of the Unified Patent Court, an order dated 26 February 2024, clarified that the party requesting a precautionary measure must, at least summarily, provide proof of the validity of the patent enforced, as the burden of proof lies with that party.

The order of the Munich Local Division

By decision of 19 September 2023, the Munich Local Division of the Court of First Instance granted 10xGenomics a preliminary injunction against NanoString in respect of patent EP 4108782, which covers a method for detecting a plurality of analytes in a cell or tissue sample. NanoString’s allegedly infringing products enabled high-sensitivity subcellular imaging of large numbers of RNAs or proteins directly from single cells in intact tissue samples.

The case did not go unnoticed, as it was the first public hearing of the Unified Patent Court.

The Local Division’s injunction was based, among other grounds, on the assumption that the Court would have found the applicant’s patent to be valid with a “sufficient degree of certainty”, in the subsequent proceedings on the merits.

In its appeal against the measures ordered by the Court, NanoString had claimed that the validity of the opposing patent had not been sufficiently established for the purposes of obtaining the injunction, and that it was “more likely than not” that the challenged patent would be found not to be valid.

The order of the Court of Appeal: the likelihood of validity of the patent and the allocation of the burden of proof

Since the preliminary injunction was issued in a summary proceedings, with limited opportunities for the parties to submit facts and evidence, the Court of Appeal agreed with the Local Division that the burden of proof should not be set too high, especially where the long period of time required for full proof would cause significant delay and irreparable prejudice to the patentee, thus undermining the reasons for precautionary protection. On the other hand, the Court specified that the level should not be too low either, precisely in order to avoid that the party against whom the precautionary measure is requested is harmed by a provisional order, granted on the basis of an invalid patent, and subsequently revoked.

Rule 211(2) of the Rules of Procedure, read in conjunction with Article 62(4) of the Agreement on a Unified Patent Court, provides that the Court may require the party requesting provisional measures to provide reasonable evidence to satisfy the Court with a sufficient degree of certainty that the applicant is entitled to commence proceedings under Article 47 of the Agreement, that the patent is valid and that the patentee’s right is being infringed or that infringement is otherwise imminent.

Such a sufficient degree of certainty requires the Court to consider at least that it is “more likely than not” that the applicant has the right to commence proceedings and that the patent is being infringed. Conversely, there is not a sufficient degree of certainty if the Court finds, on the basis of a balance of probabilities, that the patent is invalid.

This newsletter is for the sole purpose of providing updates and general information and is not intended as legal advice on any particular or specific issue.
For clarifications or information, please contact the authors or your reference professional at the Firm.

Niccolò Ferretti, Partner
T.: +39 026575181

Emanuela Gaia Zapparoli, Counsel
T.: +39 026575181

Daniele Caponetto, Associate
T.: +39 026575181

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