Key decisions at the EPO and UPC - August edition

Part 1 - T 1809/20 - TBA continues strict standards for added matter 

Relevance of the decision

T 1809/20 published on August 26, 2024 confirms the standard European practice that selections out of multiple lists are not allowable, even if each individual embodiment is disclosed in the original application and even if the embodiments out of which a selection is necessary are standard parameters. Consequently, T 1809/20 confirms the very strict standards of the EPO regarding added matter. This decision may also be relevant for UPC cases, since the UPC is currently adopting EPO added matter standards (see decision of the LD The Hague in Abbott v Sibio, discussed in the July edition of this newsletter).

General Principles

According to standard EPO practice, any claimed subject-matter must be directly and unambiguously derivable from the application as originally filed (confirmed in e.g. G2/10). It is further standard practice of the EPO that selections out of two or more lists are not allowable. A selection, however, is not present if there is a pointer to a given embodiment. Such a pointer may be found either in a designation of such embodiment as preferred over other embodiments or in an example. In the absence of such a pointer, there is added matter and a violation of the requirement of Article 123 (2) EPC. These principles have now been confirmed in T 1809/20.

The reasons/decision 

Claim 1 of the underlying patent EP2513134B1 reads as follows

¨1. A method of producing a purified protein of interest antibody, antibody fragment, or Fc fusion protein, using an affinity chromatography (AC) matrix to which the protein of interest antibody, antibody fragment, or Fc fusion protein is bound, the method comprising:
a) loading a mixture comprising the antibody, antibody fragment, or Fc fusion protein onto the AC matrix; and
b) washing the AC matrix with one or more a wash solutions comprising both (i) arginine, or an arginine derivative selected from the group consisting of acetyl arginine, N-alpha-butyroyl-arginine, agmatine, arginic acid and N-alpha-pyvaloyl-arginine, at a concentration in a range of 0.05-0.85 M, and (ii) a nonbuffering [sic] salt prior to elution of the protein of interest at a concentration in a range of 0.1-2.0 M, wherein the pH of the wash solution is greater than 8.0, and wherein the wash solution removes impurities from the AC matrix; and
c) eluting the antibody, or antibody fragment, or Fc fusion protein, from the AC matrix;
with the proviso that if a purified Fc fusion protein is produced, the AC matrix is selected from the group consisting of a Protein A column, a Protein G column, a Protein A/G column and a Protein L column." (Emphasis added; strikethrough representing deletion and bold text representing addition, compared to claim 1 as filed.)

As can be seen above, claim 1 has been amended in multiple ways compared to claim 1 as filed. During opposition proceedings, there has been no dispute that each feature of claim 1 granted is found in the original application. However, said disclosures were only found in several lists, and there was no indication that the specific embodiment was preferred over another. The conditions used in the examples fall under those claimed, but the Board found that they also fall under other embodiments in the general description. For these reasons, the Board concluded that there was no pointer to the specific combination of features claimed in claim 1, with the consequence of added matter.

The decision, although in line with EPO standards, appears to be quite strict, because the claimed conditions and antibody formats are standard and it is hard to believe that the skilled person would not have contemplated them. It appears that the Board has again looked for an 'easy way out'.

Take Home Message 

This decision again provides guidance for future applicants how to draft applications under EPO standards. It is indispensable that each potentially commercially important feature combination must be individualized in an application. Furthermore, T 1809/20 again makes it clear that fall back positions are limited, should such individualization not be disclosed in the original application, even in cases where the individual but not individualized parameters are standard conditions. The decision also confirms that, principally, examples may serve as pointers to a specific embodiment otherwise only disclosed in a list.

Part 2 - Developments in access to documents at the UPC 

Significance of this issue

Access to court documents became an early front runner amongst more fundamental questions about how the UPC would govern itself on issues like open justice. 

In our May edition, we reported on the seminal Court of Appeal decision in Ocado and how it had been applied to grant access to a UPC court file in NJOY by an EPO opponent. 

Here, we report on some recent decisions, the majority of which are from law firms, who continue to be a prominent applicant in this area. In fact, it is the law firm requests that have been successful in the recent cases, leaving a request from a court user / industry applicant as an arguably more standout rejection. We unpick these decisions and consider some of the take home messages below. 

Recent decisions 

We address the following 4 orders:

• Decision of the Hague Local division dated 29 July 2024, relating to Abbott v Sibio

• Decision of the Vienna Local division dated 12 August 2024, relating to SWARCO v STRABAG 

• Decision of the Paris Central Division  dated 29 July 2024, relating to Bitzer v Carrier

• Decision of the Munich Central Division dated 22 August 2024, relating to Astellas v Healios

As the titles show, these cover a spread of local and central divisions of the UPC. Each decision is also given by a different (single) Judge. 

Starting with the last two in the list above, both of these decisions arise from applications made by Mathys & Squire. Both of these applications are in cases that have now ended/settled. All of the named parties are noted as having made no objection (or comment) to the request, except Astellas who objected on the basis of the applicant having an insufficiently direct or immediate interest. In this respect, the main reasons relied upon in each of these requests are of a more general nature, namely interest in the UPC's activities, rather than e.g. representing a client (unless they wished to remain anonymous). This is also inferred by the number of requests being made by the firm in question, who were also involved in the Ocado appeal.

The application in Bitzer v Carrier was more recent (in June 2024), whereas the application in Astellas v Healios was older (in November 2023), having been stayed pending the Ocado decision. Perhaps due to Astellas' objection, the latter decision is more extensive and reasoned; in particular, it addresses the specific mechanics of the request, including the allowance of redactions requested by Astellas and delaying access pending appeal (inferring that access would be stayed should Astellas appeal). 

In any event, the successful outcome in both of these decisions affirms the lower hurdle for access in ended/settled cases. That was also the key issue underlying the other successful law firm application - the first listed case above - in Abbott v Sibio.  This was likewise a very general request/interest expressed by the firm in question (Powell Gilbert), but the key differences were that the proceedings concerned provisional measures that were pending appeal and that both of the parties in the proceedings in questions objected to the request. 

However, both parties' objection were overruled and access was granted. In contrast to the orders obtained by Mathys & Squire, no opportunity was given for redactions (either of information Abbott alleged to be confidential or the parts that it argued contained arguments that were not progressed and/or covered in the public outcome). However, like the order in the Astellas case, access was granted, but suspended for 15 (not 16) days pending any appeal. The fact that the case in question was under appeal did also not render any change in the UPC's view that it was ended, thereby requiring only the lower threshold for access to be overcome. 

Lastly, is the case of SWARCO v STRABAG, in which the applicant was DMV (a Serbian company) . Notably, the UPC case in question is ongoing, thereby invoking the higher threshold and needing to overcome the balance in favour of maintaining the integrity of the proceedings. It was also opposed by the patentee/plaintiff. 

In terms of the facts, DMV is involved in national proceedings in Slovenia between the same parties, and so appeared to be concerned that it might also be sued for patent infringement in the UPC. This was the basis for its request - i.e. a direct interest in understanding the claim made against the defendant, as well as the validity of the patent. However, one of the reasons given by the UPC in rejecting DMV's request was that it was unsubstantiated and that the applicant had not sufficiently characterised its interests, its products, or their similarity to the defendant's products in the proceedings. Instead, the decision suggests that the applicant is likely to be implicated via understanding its contractual relationship with the defendant, rather than by access to documents; or it could simply look at the patent and take advice. Given the stronger interests of the integrity of proceedings, the request was rejected (with DMV having the right to appeal). 

Take Home Messages

Recent (or unstayed) law firm requests have been more successful in accessing UPC documents, but this has primarily arisen in ended/settled cases - including both settled cases and cases following first instance decisions pending appeal. Accordingly, third parties should be more confident in accessing pleadings and evidence from the court file where after trials, as long as they are not designated as confidential. 

These successful applications are also a reminder to UPC parties to ensure that they have sought to protect confidential information at the point of filing due to the risk of losing the chance if such later, third party requests for access are granted. It remains to be seen if further uniformity and clarity might be obtained from the UPC Court of Appeal on this issue. 

For parties with more direct interests, DMV were unsuccessful, compared to the success recently obtained by Nicoventures in the NJOY case. Therefore, it remains to be seen if any appeal might put infringement on a level par with validity interests stemming from parallel EPO proceedings.  

But overall, despite some rejections, a positive trend is emerging so hopefully an equally positive sign of things to come. And with transparency and access so diverse across European national courts, clarifying and unifying rules of access look set to remain a primary objective for UPC users. Of particular note is also the time and costs of these requests - requiring representation, application, comments from the parties, hearings, reasoned decisions, appeals, redactions, etc. Even where the thresholds are lower following the end of proceedings, it seems likely that this burden will remain on the court (i.e. rather than the parties) to provide documents. With IT/CMS reforms underway but a long way off, this burden looks likely to remain and may not be alleviated by any automation or improved public access via the CMS.