UPC revocation actions: What is a reasonable number of auxiliary requests?

10x Genomics, Inc. and Harvard College v Nanostring Technologies Inc. (UPC_CFI-298/2023), Munich Local Division (13 January 2025) 

Nanostring had brought proceedings against 10x Genomics and Harvard to revoke a patent relating to detection reagents, compositions and methods for detecting, and quantifying analytes in a sample. In its defence, Harvard had filed 55 auxiliary requests to amend the patent and there was a question whether this was a reasonable number in the circumstances of the case. The parties had agreed that the UPC proceedings should be stayed pending a decision of the Opposition Division in parallel EPO proceedings. 

Judge rapporteur

In October 2024, the judge ordered¹  that:

1. the UPC proceedings should be stayed until the decision of the EPO Opposition Division; 
2. the number of auxiliary requests should be limited to a single-digit number (i.e. less than 10); and  
3. given the stay, the limited number of auxiliary requests needed to be submitted within 20 days of the Opposition Division’s decision (when the stay would be lifted).

Appeal to full panel 

Harvard asked for a panel review of the decision to reduce the number of allowable auxiliary requests. 

The full panel reasoned that it would be absurd to stay UPC proceedings because of parallel EPO proceedings but then refuse to introduce in the UPC proceedings an auxiliary request that had been the subject of the EPO proceedings. Accordingly, Harvard should be allowed to adjust its auxiliary requests after the decision of the Opposition Division, to take account of what happened before the EPO. The judge rapporteur was therefore right to give Harvard the opportunity to adjust its auxiliary requests within 20 days of the decision of the Opposition Division. 

However, the judge rapporteur was wrong to reduce the number of auxiliary requests to a one-digit number. As had been stated in Merril v Edwards Lifesciences (UPC_CFI_255/2023, ACT_551308/2023), the  question of whether the number of auxiliary requests is reasonable needs to be assessed in light of the scope of the particular counterclaim for revocation. Whilst 55 auxiliary requests is a high number, potentially hindering the efficiency of the UPC proceedings and the goal of delivering expeditious decisions, it wasn’t unreasonable, considering the extreme complexity of the case (in particular, the 42 grounds of invalidity raised), the importance of the patent at issue and the interrelationship with other proceedings, both judicial and administrative.  Furthermore, pursuant to the principle of fairness set out in Art 42 UPCA, the patentee, as a defendant to a revocation counterclaim, should have the right to defend against all attacks brought in the counterclaim. 

Accordingly, the relevant order was revised to allow the patentee to submit its auxiliary requests within 20 days of the Opposition Division’s decision. The court couldn’t assess whether the number of auxiliary requests would ultimately be determined to be reasonable so that question would remain unanswered until a later stage. In any event, a high number of auxiliary attacks would not necessarily be unreasonable in light of the numerous validity attacks in the counterclaim. The decision of the Opposition Division would also be taken into account. 

Key Takeaways 

This appears to be a sensible decision at the particular stage of the proceedings, which emphasises the need to consider the specific circumstances of each case at the appropriate stage of the proceedings.  It also highlights the importance of allowing patentees to adjust their auxiliary requests based on developments in related EPO proceedings.

When deciding what is a reasonable number of auxiliary requests, the court should look at:

1. the complexity of the case, in particular the number of invalidity grounds raised; 
2. the importance of the patents in issue; and 
3. the interrelationship with other proceedings. 

This decision also implies that there is no fixed numerical figure for the reasonable number of auxiliary requests, even if, in particularly complex cases, the number is large.  It all depends on the circumstances of the case. Indeed the Paris Central Division in Merril v Edwards Lifesciences had allowed the number of amendments originally filed, even there were 84 auxiliary requests, because of the extreme complexity of the case, the grounds of invalidity raised, the importance of the patent at issue and the interrelationship with other proceedings concerning related patents of the same family. 

NJOY Netherlands B.V. v. Juul Labs International, Inc. (UPC_CFI_316/2023), Paris Central Division (17 January 2025) 

This decision was given by the Paris Central Division four days later and it confirms the principle that large numbers of auxiliary requests need to be justified in the circumstances of the case. 

The proceedings concerned a revocation action brought by NJOY against Juul Lab’s European Patent EP 3 430 921 B1 for vaporizer technology on grounds of added matter, lack of novelty, and lack of inventive step. Juul Labs, in its defence, filed an application to amend the patent, which initially included 57 auxiliary requests. 

The auxiliary requests filed by the defendant were not examined by the Court, as the revocation action was dismissed, and the auxiliary requests were conditional on the revocation of the patent as granted. However, the Court made some procedural statements regarding the admissibility of the auxiliary requests, which are relevant for the analysis of the case law.

Notably the Court highlighted that, in June 2024, an order gave Juul Lab the option to narrow down the auxiliary requests already on file and in October 2024 Juul Labs identified 12 auxiliary requests to be pursued at the oral hearing. The court considered to this to be expedient for an efficient procedure. 

The court rejected a further request to review 65 auxiliary requests, so far as they went further than the 12, because this was an unreasonable number in the circumstances of the case. The Court considered that the proposed 12 conditional amendments that formed the 12 auxiliary requests were the upper limit for what could be considered reasonable in this particular case.

This decision also illustrates the issue of the admissibility of supplementary auxiliary requests. In this case, Juul Labs filed a new auxiliary request with the UPC shortly after a decision of the EPO raised doubts about the clarity of the claims. However, the UPC considered this new auxiliary request as late filed, since the clarity objection had been raised by NJOY, and Juul Labs should have taken it seriously earlier. This is consistent with the UPC’s case law, which emphasises that parties are under an obligation to set out their full case as early as possible under the front-loaded system of the UPC proceedings, according to Preamble RoP 7 (UPC_CFI_263/2023, CD Paris, Bitzer v Carrier Corporation; UPC_CFI_252/2023, CD Munich, Nanostring v Harvard). The UPC also takes into account the arguments already submitted by the claimant for revocation when assessing the admissibility of a new amendment (UPC_CFI_219/2023, LD Mannheim, Panasonic v Xiaomi; UPC_CFI_210/2023, LD Mannheim, Panasonic v Orope). Therefore, it is advisable for patent holders to consider all the invalidity grounds as serious and to prepare auxiliary requests accordingly.

Conclusion 

The admissibility of auxiliary requests is subject to both formal and substantive criteria, which are governed by the RoP and the European Patent Convention (EPC). The formal criteria set out in the RoP include the timely filing of the request to amend the patent, the provision of an explanatory statement, and the clarity, conciseness and support of the amended claims. The substantive criteria include compliance with the provisions of the EPC, such as the prohibition on adding subject-matter and extending protection, and the prima facie admissibility of the amended claims, which means that they must address the grounds for revocation raised by the claimant. In addition, the Court has the discretion to assess the admissibility of auxiliary requests, taking into account the principles of procedural efficiency, fairness and proportionality, as well as the specific circumstances of the case. The Court may also invite the patent holder to reduce the number of auxiliary requests, in order to facilitate the Court’s examination of the admissibility of the amended claims. 

1. ^{ORD_51811/2024; ORD_51812/2024; ORD_51813/2024}