The Central Division (Munich) has handed down a significant revocation decision in the ongoing patent battle between NanoString v 10x Genomics and President and Fellows of Harvard College. This follows the Court of Appeal’s decision earlier in the year in relation to another (closely related) patent, in which it set aside a preliminary injunction ordered by the Munich Local Division, holding that the patent was (more likely than not) invalid - see summary here.
By way of brief background, the patent EP 2 794 928 B1 (the “Patent”), owned by President and Fellows of Harvard College, concerns spatial profiling technology, adopting an in situ method for detecting RNA. NanoString brought these proceedings before the Central Division, challenging the validity of the Patent and seeking for it to be revoked in its entirety.
Much of this decision focusses on whether claim 1 of the Patent (as granted and in amended form) is novel and comprises an inventive step over the key prior art document, Göransson, which related to in vitro methods of analysing samples of extracted DNA.
However, the decision is also noteworthy in exploring the UPC’s jurisdiction to hear revocation cases where parallel revocation proceedings in national courts are also in foot.
These aspects of the decision are explored in more detail below.
JURISDICTION
Following service of the revocation claim, the Defendant lodged a Preliminary Objection, arguing that the Court lacked competence to decide on the German part of the Patent, pursuant to the lis pendens rules under Brussels I Recast Regulation.
In brief, the lis pendens rules prescribe that, where proceedings involving the same cause of action and the same parties are brought in the courts of different Member States, the court ‘first seised’ has jurisdiction such that the other court(s) shall decline jurisdiction in favour of that court (Article 29 of the Brussels I Recast Regulation). Moreover, a court can exercise its discretion to stay proceedings before it where a related action is pending before another court (Article 30 of the Brussels I Recast Regulation).
The objection was raised on the basis that a revocation action with respect to the Patent was already pending before the German Federal Patent Court, being the court first seised. The German designation of the Patent had in fact been held invalid earlier this year by the German court, but such decision is currently under appeal (the final outcome not expected for at least another year).
Importantly, however, the claimant in the German proceedings is not the same entity as in the present UPC proceedings, but rather a German entity in the same corporate group as NanoString Technologies Europe Limited (the claimant in these proceedings). The Defendant argued that the NanoString entities’ interests in the revocation actions are the same and unable to be distinguished.
The Defendant had in fact withdrawn its objection at the oral hearing. However, the Court made clear that it must assess its international jurisdiction on its own motion when this is required under Union law and therefore proceeded to determine the issue.
The Court acknowledged that the grounds, facts and arguments relied upon by the parties in the parallel proceedings were largely similar. However, applying the reasoning adopted by the Court of Appeal in Mala Technologies/Nokia Technologies (UPC_CoA_227/2024), it ruled that the respective claimants in the pleadings were not the same parties as required by Article 29 Brussels I Recast Regulation. Being part of the same corporate group is not sufficient for these purposes, and therefore the Central Division was not required to stay the proceedings in favour of the German courts.
The Court also chose not to exercise its discretion to stay proceedings pursuant to Article 30 Brussels I Recast Regulation. The Court set out a variety of factors which supported the fact that the interests of the parties and procedural economies outweighed the risk that appeal proceedings may be pending in both forums in parallel (with a further risk of contradictory decisions being rendered). Importantly, any appeal decision in the UPC will likely be handed down before a final outcome in the German appeal proceedings (which is at an early stage). The Court considered that staying the UPC action only in respect of the German part of the Patent would have little benefit in terms of procedural economy given the revocation claim and defence would still have to be determined in respect of the other national parts of the Patent.
The Central Division therefore concluded that it had (international) jurisdiction to hear this claim, to the extent it relates to the German part of the Patent.
Relying on the same factors, the Court stated that it would have reached the same conclusion on the basis of Rule 295(m) UPC Rules of Procedure (“RoP”), which gives the Court a general discretion to stay proceedings where so required for the ‘proper administration of justice’. It also referred to the principle of efficient and expeditious decision making, which underlies UPC procedure. The Court thereby determined that it would not be in the interest of the proper administration of justice to stay proceedings pending the outcome of the appeal proceedings in Germany.
ADMISSIBILITY OF APPLICATION TO AMEND
The Defendant lodged a new Auxiliary Request 2 less than 6 weeks before the oral hearing. The Court emphasised that, bearing in mind the front-loaded nature of UPC proceedings, parties should particularise their case in full as early as possible. On this basis, permission to amend the Patent in line with Auxiliary Request 2 (pursuant to Rule 50.2 RoP) was not granted, with the Court being unconvinced that the Court of Appeal order handed down in February (which ruled on claim construction) meant the Defendant could only file the Application to Amend at this stage in the proceedings.
VALIDITY
Claim interpretation
The Court underwent the task of interpretating several features of claim 1, in accordance with the Court of Appeal’s guidance in NanoString/10x Genomics – see summary here: [insert link to UPC hub article on this].
The Court also confirmed that a patent claim is to be interpreted at the filing (or priority) date of the application which resulted in the patent in suit.
Skilled person
The Court then identified the skilled person as someone having a degree in biological sciences (or biochemistry) and several years of experience in the field of detection of biomolecules in biological samples. Such person would be familiar with both in vitro and in situ techniques for the detection of biomolecules.
Novelty
The Court then went on to assess novelty.
It made clear that the assessment of novelty (pursuant to Art. 54(1) EPC) requires the determination of the whole content of the prior publication. It explained that, if the subject-matter of the claim with all its features is “directly and unambiguously disclosed” in the prior art, the claim will lack novelty.
It overall concluded that claim 1 of the Patent lacks novelty over Göransson, with all features being disclosed in this prior art document. In doing so, it determined that claim 1 of the Patent, as granted, is not limited to in situ detection or analysis (whether by reference to the claim language or the wider specification).
It considered that the amendments made in the auxiliary requests established novelty over Göransson, and therefore the Court went onto assess inventive step in respect of the auxiliary requests on file.
Inventive step
The decision provides a clear structure by which the Court is to approach the assessment of inventive step. In summary:
- Inventive step is to be assessed from the perspective of the skilled person on the basis of the state of the art as a whole, including the skilled person’s CGK.
- The ‘decisive factor’ is whether the claimed invention follows from the prior art in such a way that the skilled person, utilising their knowledge and skills, would have identified it by, for example, making obvious modifications to the matter disclosed in the prior art.
- A first necessary step is to determine a realistic starting point in the state of the art. A starting point will be deemed ‘realistic’ if its teaching would have been of interest to the skilled person who, at the priority date of the patent, was seeking to develop a similar product or method to that disclosed in the prior art which addresses a similar underlying problem as the claimed invention. However, the Court acknowledged that there may be several realistic starting points, and so it was not necessary to identify the “most promising” starting point for further development.
- The claimed subject matter must then be compared to the teaching in the prior art. Having done this, the next question is whether it would be obvious for the skilled person, having started from a realistic starting point, in view of the underlying problem, to arrive at the claimed solution. If the solution would not be obvious in this context, the invention claimed would involve an inventive step (in compliance with Article 56 EPC).
- A claimed solution will be obvious if, starting from the prior art, the skilled person would be motivated to implement the claimed solution. However, it may be relevant whether the skilled person would have expected to face barriers in taking any such next steps.
- Depending on the facts and circumstances of the case, the skilled person may be permitted to combine prior art disclosures.
- A technical effect or advantage achieved by the claimed subject matter, over and above the prior art, may be indicative of an inventive step. However, a feature that is selected in an arbitrary way, out of various possibilities, cannot generally contribute to an inventive step.
- It is important to avoid hindsight in performing such an assessment.
The Court determined that, as Göransson discloses all the features of claim 1 as granted, this prior art can be considered a realistic starting point for the assessment of inventive step. Moreover, it considered that the Patent and Göransson both:
- concern optical methods for the multiplex detection of target molecules in a sample and, therefore, share the same underlying problem.
- address the need to increase the number of analytes identified with a limited number of available “colours”.
By reference to the above considerations, the Court’s view was that both seek to address the same underlying problem.
The Court then determined that it would be obvious for the skilled person at the priority date, starting at Göransson, to transfer to an in situ method for detecting RNA or proteins, thereby arriving at the claimed solution. Without the benefit of hindsight, the skilled person would be motivated to do so, as a next step. The Court reached this finding based in part on a PhD thesis submitted in the proceedings, which formed part of the state of the art.
The Court also considered Göransson to indicate that the skilled person would not have expected any particular technical difficulties in transferring the method disclosed in Göransson from an in vitro method to an in situ application. None of the problems put forward by the Defendant were mentioned in the Patent as “in situ problems” (nor did the Patent offer any solutions for these alleged problems). In the Court’s view, this created a strong indication that these problems would be readily addressed by the skilled person if they occurred.
The Court concluded that it would have been obvious for the skilled person to, starting from the disclosure in Göransson, arrive at the subject matter claimed in each of the auxiliary requests.
OUTCOME
The Patent was revoked in its entirety on the ground of lack of novelty, with the auxiliary requests being unable to save the Patent from revocation due to lack of inventive step. The Court therefore did not consider it necessary to opine on the other grounds for revocation raised by the Claimant.
The Court acknowledged that it reached the same conclusion as the German Federal Patent Court on similar grounds, and that its decision was also in line with the CoA’s finding on validity earlier this year in the related proceedings.
OBSERVATIONS
The UPC’s assessment of inventive step seems to now be clearly articulated, at least at first instance. The approach adopted appears to more closely align with national German practice than the EPO’s more rigorous problem-solution approach – although it is noteworthy that another recent decision rendered by the Hague Local Division has expressly applied the EPO’s approach (see page 26 of this decision). Whilst the identification of a suitable starting point is similar to the EPC’s closest prior art doctrine, the Court did not address the ‘objective technical problem’ to be solved (i.e. the technical effect that flows from the novel feature in the claimed invention, which distinguishes it from the prior art). Rather, it focussed on the underlying problem (i.e. the problem that the patent says the invention solves). That is not to say, however, that the problem-solution approach would have led to a different outcome in this case and, arguably, the differences in approach are subtle. The Court also recognises that certain situations may permit the combination of prior art disclosures, as commonly done in the problem-solution approach.
In contrast, the Court has clearly adopted the EPO’s test of “direct and unambiguous” disclosure for assessing novelty.
This decision also makes clear the need to present convincing argumentation in favour of a stay of proceedings, in order to persuade the Court to exercise its discretion under Article 30 of Brussels Recast. Ultimately, as national revocation proceedings will often concern only one aspect of a European patent, there may well be procedural economies in the later filed UPC action (covering all member states designated by the patent) running in parallel. This is particularly where a final outcome in the UPC is to be expected sooner (which may well be the case, given the speedier procedural timelines in the UPC compared to many national procedures).
However, we await to see whether an appeal is filed, which may provide more authoritative basis for the tests and principles explored in this decision.
