Key decisions in European patent disputes from the EPO and UPC

European patent update – key decisions at the EPO and UPC

We cover some recent key decisions in European patent disputes, this time in the EPO and Unified Patent Court (UPC)

Part 1 – T1437/21

Relevance of these decisions

Given the significance of patents in the field of medicaments, many pharmaceutical companies file second (and further) generation patent applications to extend patent protection to secondary (and further) applications of certain drugs. One of the later stage patent applications filed often covers the results of the clinical trials. Since these trials are often announced and / or results are often at least partially available before the filing the conclusion of the trials, there is a huge debate about the relevance of such prior art for the patentability of these applications. T1437/21 of February 9, 2024 provides further insights in this regard.

General Principles

Although it appears to be self-evident, the most important message from T1437/21 is that prior art disclosing already conducted clinical trials or describing any future clinical trials has to be assessed on its individual content alone based on the legal practice of the EPO. The fact that everybody knows that in a clinical trial, all possible details of a pharmaceutical product or of its administration are known to at least some people involved in the trials is irrelevant.

The reasons/decision

In T1437/21, patentability of the following claim has to assessed by the Board:

" Empagliflozin for use in a method for treating prediabetes, type 1 or type 2 diabetes mellitus in a patient or for improving glycemic control in a patient with prediabetes, type 1 or type 2 diabetes mellitus comprising administering empagliflozin to the patient, wherein the patient has moderate renal impairment or stage 3 chronic kidney disease (CKD) or wherein the patient's estimated glomerular filtration rate (eGFR) is ≥30 ml/min/1.73 m2 and <60 ml/min/1.73 m2 ” (emphasis added)

The most relevant prior art D22/D29, which were press releases from the Patentee, reported the effective treatment of type diabetes (“T2DM”) in patients having mild, moderate or severe renal impairment by daily administration of 25 mg of empagliflozin, an SGLT-2 inhibitor, in a Phase III clinical trial. The Board decided, in accordance with the very strict practice of the EPO regarding a direct and unambiguous disclosure - and in contrast to the Opposition Division - that this generic disclosure is not novelty destroying for the present claim directed to the patient sub-population with moderate renal impairment. Since also no further relevant data on the patient groups of the trial were disclosed in D22/D29, novelty was acknowledged.

As to inventive step, the Board came to the conclusion that, in accordance with T 2963/19,

“… the approval of a clinical study depends on the assessment of the foreseeable risks to the participants in relation to the anticipated benefit in terms of the relevance of the findings. The approval of a clinical trial does therefore not, by way of a heuristic, imply an expected positive outcome of the treatment”. (see Point 4.3.1, second paragraph of the decision).

The Board, therefore, and in accordance with the classical approach of the EPO, checked first that the patent makes it credible (although this term is not used in the decision) that empagliflozin can be used to treat T2DM in patients with moderate renal impairment. Then, the Board assessed whether or not, based on the information publicly available at the priority date of the patent, the skilled person had a reasonable expectation of success that T2DM patients with moderate renal impairment could be treated with empagliflozin. The Board came to the conclusion that in the announcements in D22/D29, although these press releases reported the successful conclusion of the clinical trial, the result for the subgroup “moderate renal impairment” was purely speculative (see point 4.3.3 of the decision). Information regarding the safety of the product for patients with renal impairment was also not considered sufficient. In addition, information on other SGLT-2 inhibitors was also considered as irrelevant, since some of the inhibitors lacked significant efficiency in patients with moderate renal impairment, for another the efficacy was not known and still another had another selectivity profile. Therefore, the Board concluded that there was no reasonable expectation of success and acknowledged inventive step.

Take Home Message

The take home message of T1437/21 for applicants, patentees and third parties is that even a report on a successful completion of a clinical trial for a given therapy may not preclude patentability. It very much depends on the circumstances of the case; and in this case, the lack of disclosure with respect to a particular patient sub-populations proved to be determinative. However, it remains noteworthy as to how strict on one hand the EPO applies the standard of direct and unambiguous disclosure (as for novelty and other grounds, such as added matter), compared to how flexible, if not lenient EPO practice can be for inventive step in a specific case. Therefore, for inventive step, storytelling and the specific circumstances in question remain some of the most important tasks.

Part 2 – EPO opponents get access to UPC documents

Relevance of decision

Access to court documents and open justice have been ever-present themes in the UPC’s debut year. Numerous interested parties from users, lawyers and the press have shown a strong appetite for gathering all and any information. Reasons for such access were not just to test how the new court would conduct itself in these respects, but no doubt arose for one of the many typical reasons; e.g. to understand and develop new litigation strategies, to see what was and was not working effectively to achieve winning outcomes and to inform other parties interested in the validity or infringement of the patent in suit.

With transparency and access so highly diverse across European national courts, accounting for and unifying such variable bases was always going to be an early challenge for the UPC, not least while it got to grips with its own administrative processes and IT systems.

In the end, an early request about a settled case from the Helsinki regional division between Ocado and Autostore rose to the fore as a test case, with the Court of Appeal eventually handing down its decision in April 2024. We look briefly at the guiding principles from that case and how they have been applied in a more recent request in the NJOY v Juul UPC case.

The guiding principles for access

Ocado was a settled case, and so the UPC Court of Appeal was able to consider and distinguish between active and settled/ended cases in terms of the thresholds that needed to be surpassed in order to access documents.

Further, the nature of the request, by a UK lawyer who was not at the time a UPC representative, the fact it was quite swiftly granted and how the Court of Appeal composed its panels, also gave rise to some further important procedural findings.

In short summary, we consider the guiding principles from this case are that:

1. A UPC representative is needed to make (or support) a reasoned request – in many circles, the inference that access to documents is a contested procedure and onerous or costly procedure was viewed as an unfavourably context to make what should be a straightforward request, but this nonetheless remains a baseline requirement. In Ocado, the UK lawyer was given the opportunity to appoint such representatives (and in fact, becoming one themselves).

2. Not all appeals need Technically Qualified Judges – while rather distant from the core issues in the case, the fact the Court of Appeal proceeded with only 3 legally qualified (and no further technically qualified judges), became an interesting outcome, not only as to how the UPC Court of Appeal would conduct itself, but also how they might interpret provisions of their founding legislation in a manner quite clearly divergent to the otherwise clear, literal wording.

3. The overarching principle is that the UPC register is public and the proceedings are open, subject to balancing any appropriate interests to the contrary (including confidentiality, data protection, protecting the integrity of proceedings and public order).

4. Requests for access must be “reasoned” – this means they must set out the purpose and need for access so that the UPC may balance interests accordingly.

5. A “specific interest” (or more “direct legitimate interest”) is a stronger basis on which to make a request, rather than a more general one – and in such cases, the balance is more likely to fall be in favour of access (perhaps with safeguards).

6. Once proceedings end or if they are settled, public access is generally favoured, whereas requests during active cases (to protect the integrity of proceedings) set a higher threshold.

Applying these principles, the fact that Ocado had settled meant that the reasoned request, albeit quite general in nature favoured access to the written pleadings and evidence and so (as access had already been granted), the appeal by Ocado was dismissed.

Overall, this was received largely positively and a victory for access to justice, while at the same time not leading to an obvious tidal wave of requests (albeit we understand many general requests are still being made). In particular, the decision left open a reasonable degree of uncertainty as to how the UPC would approach future access requests made during proceedings.

EPO opponents pass the test

A recent case, which had been stayed pending the outcome in Ocado, has shone more light on access to document requests made in the context of parallel litigation.

Nicoventures was an EPO opponent against a Juul patent in the field of electronic cigarettes. NJOY, which is said not to be one of the multiple EPO opponents, brought UPC revocation proceedings against the same patent. And so Nicoventures made a request to access a wide array of documents from NJOY’s UPC case given the potential insights and impact on the parallel EPO opposition. Juul objected to all of Nicoventures’ requests, whereas NJOY only objecting to the more far reaching ones (in particular the request for future documents not yet known).

To summarise what we consider to be the key outcomes:

A) Parties opposing the same patent in parallel proceedings have a direct interest in written pleadings and evidence in UPC proceedings – this puts EPO opponents in a strong position, but the reasoning would seem to any party seeking revocation in any parallel proceeding against an EP involved in UPC litigation. The UPC emphasised that revocation proceedings are likely easier to justify a public interest, rather than infringement proceedings.

B) Access can be swift – the UPC awarded immediate access due to the nature of the request and potential impact on the EPO opposition (likely also influenced by the stay pending the Ocado decision).

C) Confidentiality is up to the opposing party – here, no confidentiality request was made and so full, unredacted access was granted.

D) No access to Court generated documents – the UPC refused these broader aspects of Nicoventures’ request. While the court may have restricted access based on the wording of the relevant rules, court orders are typically public in many court proceedings and so public access thereto would seem to be an area where the UPC should consider this more broadly/administratively.

E) No access to future of not yet visible documents – the UPC was also restrictive in this respect, which perhaps unfortunately as a practical matter will mean that parties need to make repetitive requests once new documents are uploaded. However, with the guiding principles of the UPC more clear and once practice becomes more established, there is a chance that these matters may be dealt with inter-parties and without UPC court applications.

Take Home Messages

Overall, the consensus is that these decisions are a positive step towards open justice at the UPC, albeit some scepticism remains, including the need to have legal representation to make requests. Given this is a modern court with a fully electronic filing system, it is hoped by many that access to documents should become smoother and more administrative (as well as open). However, this seems likely to take some time given the number of challenges and developments already being raised in relation to the UPC’s IT systems.