Provisional injunctions against alleged infringers under Article 62(1) of the Agreement on a Unified Patent Court (UPCA) may be granted across the entire UPC territory: a market of over 300 million people. To this end, the court may require the applicant to provide reasonable evidence in order to satisfy itself with a sufficient degree of certainty that the applicant is the right holder and that the applicant’s right is being or will imminently be infringed (Article 62(4) UPCA). Furthermore, Article 62(2) UPCA provides the court with the discretion to weigh up the interests of the parties and take into account the potential harm resulting from granting or refusing the injunction.

The court’s Rules of Procedure further specify that in taking its decision on the provisional measure, the court ‘may’ require the applicant to provide evidence to satisfy the court with a sufficient degree of certainty that the patent in question is valid (Rule 211(2) RoP). Furthermore, the court ‘shall’ have regard to any unreasonable delay in seeking the provisional injunction (Rule 211(4) RoP).

These provisions have been given a bit more life in yesterday’s and today’s first UPC hearing on an application for provisional measures (File number: ACT_459746/2023). The parties were 10x Genomics, Inc. and President and Fellows of Harvard College (applicants, respectively licensee and patentee) on one side, and US, German and Dutch entities of NanoString Technologies (defendants) on the other side. The patent at issue was EP 4108782, granted to President and Fellows of Harvard College as a unitary patent (and opposed at the EPO by NanoString’s US entity).

The application was heard at the UPC’s Munich local division by a panel of judges consisting of Matthias Zigann as chair; Tobias Pichlmaier as rapporteur; András Kupecz as legally qualified judge (LQJ) (who also has a background in biotechnology), and Eric Enderlin as technically qualified judge (TQJ).

After preliminary remarks by the chair stating that the panel had discussed this case in detail the day before the hearing, he summarised the panel’s preliminary opinion on various points and identified key points of contention on which the parties should focus their submissions. The identification of various minor formal points relating to the wording of the applicants’ application led to the submission of a slightly redrafted application to address these points, which the defendants did not object to (although they did object to the filing of a new auxiliary request with amended claims at the hearing – see below).

Validity

A detailed discussion of novelty of the claims was conducted.

This is very interesting as it seems to go beyond the intention of the UPC Agreement, as it does not even require that the validity of the patent asserted in provisional measures is assessed. Also, in the ex parte PI order granted by the UPC Local Division Dusseldorf in June 2023 (ORD_ 541204/2023, myStromer AG v Revolt Zycling AG), the panel simply stated that they were not convinced by the protective letter’s invalidity arguments without giving any hint as to whether these had been studied in detail. In this week’s PI hearing, the presence of a Dutch judge being used to PI proceedings where there is a thorough review of such validity and going well beyond prima facie analysis might have been instrumental. It is also worth noting that the German LQJs of the panel were those who sent the referral to the CJEU a couple of years ago (C-44/21) in an attempt to overturn the German case law according to which PIs could only be granted on patents that had already survived a validity test (at the EPO or in a court entitled to assess validity such as the German Federal Patent Court).

In essence, the court asked the parties to explain whether, in their opinion, the claims had no, one, or two differences relative to a prior art document, with the two potential differences mentioned by the court in its preliminary remarks. Whether the claims were different over the cited art hinged on how various terms and steps of the claimed method should be interpreted. Thus, a detailed discussion of the claim wording and its correct interpretation was conducted, including an analysis of different (allegedly conflicting) parts of the description and to what extent and how the description could or should be used to interpret the claims. The applicants referred to the case law book of the EPO’s Boards of Appeal on claim interpretation points in light of the description. Indeed, the validity standards applied at the UPC are the EPO ones (Art. 138(1) and 139(2) EPC are incorporated in the UPCA’s Article 65). References were also made to a parallel German revocation action for a patent in the same family and that court’s (i.e. the Bundespatentgericht, BPatG, or Federal Patent Court) preliminary opinion on the patent’s validity; in these proceedings, the claim apparently had been amended to make a certain novelty-providing interpretation explicit in the claim. The court asked in its preliminary remarks why the same amendment had not been made proactively also for the patent at issue; after these comments, the applicants filed an auxiliary claim request during the hearing aiming at mirroring such amendments (see below).

Inventive step was also discussed in detail, with the defendants arguing inventive step starting from two different closest prior art documents; one of which was the document discussed under novelty, with the defendants assuming, for the sake of argument, that the applicants’ identification of differences over this document was correct. The court again referred to the Bundespatentgericht’s preliminary opinion on these documents, asking in particular the defendants to comment on the BPatG’s opinion and why they thought it was incorrect; the court also asked why the defendants started from two documents as closest prior art and not just one, with the defendants arguing that these two were equally valid starting points but showing a preference for the document not discussed under novelty. References were also made to opinions by experts on the invention and the prior art, but the court stated that it was the quality of the argument, not who made it, which mattered – given that two judges on its panel had a background in biotechnology. This is also a highly relevant aspect as it is the first time that weight has been put on expert evidence in the UPC. It remains to be seen whether all UPC divisions will follow this approach to expert reports on the basis that there are highly qualified TQJs on the panels, and whether it will be similar in proceedings on the merit. This could mean that all cases, including PI cases, will be staffed with TQJs regardless of whether the validity side of the patent is debated (which is where appointing a TQJ is mandatory).

The parties also made brief submissions on added subject‑matter, which the court had not provided a preliminary opinion on at the beginning of the hearing. The applicants argued that there was a presumption of validity, in line with European Court of Justice case law, because the patent had been granted by the EPO; the defendants in turn pointed to Rule 211(2) according to which the court may satisfy itself of the patent’s validity. Indeed, the panel’s rapporteur said that the court would not simply presume a patent’s validity and that this hearing (i.e. with its detailed discussion of validity) showed just that.

There was further debate about which standard the UPC should be applying when considering validity under Rule 211(2) RoP. The applicants argued for a ‘balance of probabilities’ approach and so a standard that is significantly lower than that applied in German courts which look at validity “beyond reasonable doubt” in provisional measures; the defendants argued for a higher standard, namely that the court must be ‘satisfied’ with the patent’s validity which is closer to the Dutch and French approach of validity in PIs, so the judges on the panel coming from those backgrounds will certainly be more familiar with such standard.

Infringement

The court gave its preliminary view on how a certain feature should be interpreted, which was in line with the applicants’ written submissions and also the German court in the parallel infringement proceedings, and thus preliminarily held that the claims were infringed. It did not see a great need for discussion on this topic but nevertheless invited submissions from the parties. The parties, however, did not comment on these aspects any further at the hearing.

Weighing up the parties’ interests

The chair also commented in his preliminary remarks on the need to weigh up the parties’ interests. This is an important criterion for provisional measures that is stated both in the UPC Agreement and in the Rules of Procedure. Also, until now only very few cross-border PI requests were brought in Europe, such that balancing the interests of the parties in a 300 million-people market is an exercise that has not been done often by EU courts. The chair noted both the applicants and defendants in essence sold machines with long shelf lives, and buyers would additionally be required to enter into contracts with the applicants or defendants to obtain reagents and to carry out the last step of the method, which according to the defendants was carried out outside the UPC territory. A key question would be how any transactions could be reversed if the court’s decision was wrong, but in its preliminary view, the court thought that the same considerations applied to both parties and that the interests were thus balanced. In such a situation, the Enforcement Directive would suggest that the court should side with the patentee. The parties briefly commented on these aspects, offering their opposing views. In particular, the applicants argued that this case was akin to ‘generics’ cases because Harvard had invested a significant amount of money into arriving at the invention, while the defendants undercut their prices. The grounds of the decision will hopefully have more detail on why the court did not consider initially that there was a more significant prejudice to the defendants and explain whether the attempt of the claimants to have generics-type case law apply to this matter was successful.

Further ‘non-technical’ aspects and licensing questions

The court remarked in its preliminary view that either 10x Genomics was an exclusive licensee, in which case it could pursue an action, or it was a non-exclusive licensee, in which case the presence of the proprietor as co-applicant implicitly showed the proprietor’s agreement for 10x Genomics to pursue an action. The defendants asked the court to consider the licensing question in more detail, because it supposedly affected whether 10x Genomics could only sue for damages or more. In particular, the defendants argued that 10x Genomics was only a non-exclusive licensee and that, furthermore, according to US public law and practice, a licence should be granted to the defendants. Indeed, the defendants in court made an offer for a licensing agreement. The court commented that it would not be applying US public law but would take a decision by a competent US court into account when issued; and that if the defendants wanted to have licensing discussions it did not need to do that before this panel, but questioned why this offer was made only at this late stage. The court asked the applicants’ representative whether the court’s decision should be delayed until the representative had a chance to discuss the offer with Harvard, but the representative asked the court to disregard the offer in line with Rule 9(2) RoP and that the offer was anyway invalid and that the defendants were not a willing licensee, pointing in particular to the defendants’ alleged pursuit of anti-suit injunctions.

In its preliminary remarks, the chair also briefly commented that the panel did not see a market-dominating position and hence no problem with EU competition law; no further detailed submissions were made on this question, which was fairly surprising given the limited number of actors in the European market.

The chair also briefly commented on the court’s jurisdiction in his preliminary remarks, noting that one of the defendants was resident in Germany, and that also the actions in question appeared to relate to the UPC territory and e.g. occurred from Germany. This question was not discussed further.

The court also briefly commented on whether a security deposit was needed, noting that it was usually required in ex parte proceedings, but was within the court’s discretion for inter partes proceedings; the parties made further submissions on this topic, with the applicants in particular noting the high cost associated with the machines in question. It is customary for German courts to require such security with preliminary injunctions, as a security is mandatory in Germany with parties enforcing 1st instance decisions on the merits. Therefore, at least the two German judges on the panel will be used to granting such requests. Also, the size of the UPC market and potential impact described during the discussion on the balance of interests are indicators that 10x Genomics is likely to be required to place a bond in order to enforce a PI were it to be granted.

The court’s decision

The court stated that it would hand down its decision on 19th September 2023, after the hearing for the parallel case ACT_459996/2023.

Admissibility of claim amendments

After the preliminary remarks by the panel indicating outstanding questions they had on novelty, and before a substantive discussion of the issues, the applicants filed an amended claim set as an auxiliary request. The amendment apparently was in line with amendments made in parallel German proceedings for the root case, such that the claims were limited to ‘in situ’ analysis. There was a detailed discussion of whether filing such amended claims was admissible (i) in an application for a preliminary injunction and (ii) at this late stage, with the parties making references to various parts of the UPC’s Rules of Procedure, EPO law and practice, procedural law in UPC states, and even to the EU Charter of Fundamental Rights. The court did not decide on admissibility but noted that a second hearing would be required if the auxiliary request was held admissible and needed to be discussed in substance.

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