Dynamics Updates
Apple Intervenes in Confidentiality Appeals: UPC Court of Appeal Allows Intervention in Ericsson and Sun Patent Trust Cases
Apple (Intervener) in Ericsson v. AsusTek and Apple (Intervener) in Sun Patent Trust v. Vivo
UPC_CoA_631/2025[1], UPC_CoA_632/2025[2], UPC_CoA_755/2025[3], and UPC_CoA_757/2025[4] – Orders of 23 September 2025
In a cluster of orders issued on the same day, the UPC Court of Appeal allowed Apple to intervene in four different ongoing appeals related to applications for protection of confidential information.
Third parties may intervene in an ongoing UPC action if they have a “legal interest in the result” of the action. An application to intervene is admissible only if it is made in support, in whole or in part, of a claim, order, or remedy sought by one of the parties (Rule 313 of the Rules of Procedure).
Two of the appeals stem from confidentiality applications in ongoing infringement actions brought by Ericsson against ASUSTeK and Arvato. Ericsson requested an “external eyes only” confidentiality regime for license agreements, and related information, between Ericsson and third parties including Apple. The proposed “external eyes only” confidentiality regime would restrict access to the material in question to one expert from each defendant and the defendants’ outside counsel. The defendants agreed in principle to the protection of confidential information, but not to the strict “external eyes only” regime. The Court of First Instance (Milan LD) allowed the applications for protection of confidential information but rejected the “external eyes only” regime. Ericsson appealed insofar as the orders reject the “external eyes only” regime.
The other two appeals arise from confidentiality application in ongoing infringement actions brought by Sun Patent Trust against the smartphone maker Vivo. Similarly, Sun Patent Trust sought to restrict access to confidential information, including license agreements between Sun Patent Trust and Apple, under an “external eyes only” regime. In these cases too, the Court of First Instance (this time the Paris LD) allowed the applications for protection of confidential information but rejected the “external eyes only” regime, allowing three employees of Vivo access to the unredacted confidential information. Sun Patent Trust appealed.
Apple argues that its agreements with Ericsson and Sun Patent Trust contain highly sensitive business information, including materials relating to the formation and performance of the agreements, and that disclosure to Asus or Vivo’s employees could lead to Apple’s commercial detriment and an undue advantage for Asus or Vivo.
ASUSTeK argued inter alia that the Rules of Procedure provide a basis for intervention only if the applicant has a legal interest in the final outcome of the action and that a legal interest in a “side question” such as a confidentiality regime is not sufficient. The Court of Appeal dismissed this argument, noting that R. 313.2 RoP provides that an application to intervene shall be admissible if it is made in support, in whole or in part, of a claim, order or remedy sought by one of the parties.
Vivo argued inter alia that Apple has no legal interest in the outcome of the appeals because Vivo’s employees have already had access the contest confidential material under the terms of the confidentiality order from the Court of First Instance. The Court of Appeal also dismissed this argument, noting that if Court of Appeal decides to impose an external eyes only confidentiality regime, the employees of Vivo will no longer have access and will not be allowed to use the unredacted version of the statement of claims and relevant exhibits, or any further submissions and exhibits containing such confidential information, whether for the purpose of these court proceedings or any other purpose.
The outcome of the appeals remains to be seen. For the time being, it seems the UPC Court of Appeal is taking a straightforward approach to the question of third party interventions. The Court’s reasoning can be easily extended to other procedural issues in which a third party has a legal interest.
[1] https://www.unifiedpatentcourt.org/en/node/139127
[2] https://www.unifiedpatentcourt.org/en/node/139128
Beyond Borders: A Backpacker’s Take on Why Your Patent Strategy Needs a Global Mindset
A well-planned global patent strategy can protect your innovations, maximise commercial value, and reduce costly surprises down the line. Yet, amid the big-picture planning, it’s often the small details—the formalities—that make or break your protection. It’s a bit like discovering a typo in your name on a visa application just as you’re about to cross into a new country: a minor oversight can quickly become a major obstacle. These procedural requirements may seem minor, but overlooking them can derail filings, delay grants, or even result in lost rights. This article explores why these formalities matter and how to manage them effectively in a global context.
Before initiating any patent filing, it is essential to pause and consider your inventors—not just their technical contributions, but their citizenship and residency. You should also consider where your invention was devised. These factors can significantly influence your filing strategy and, if overlooked, may lead to serious complications.
Evaluating this information is extremely important when considering where to file your application first, whether a foreign filing license should be required, and if so, from which patent office. Getting this wrong could cause any application subsequently filed in a jurisdiction whose foreign filing rules were not complied with to be held invalid.
In most cases, patent applicants have flexibility in choosing where to file first. However, when an invention’s origin intersects with national legislation, that flexibility can vanish. You may even find yourself compelled to file in a jurisdiction that holds no commercial interest, simply to comply with local law.
Let’s illustrate this with the example of Greece. Under Greek law, if an invention involves a Greek national as an inventor, the first patent application must be filed in Greece—regardless of where the invention was made or the nationality of the applicant. This isn’t a procedural preference; it is a legal obligation. Failing to comply could invalidate subsequent foreign filings and even trigger criminal sanctions.
Several other countries also have their own restrictions, and a helpful summary is available via the WIPO website. If there’s any uncertainty, seeking advice from a locally qualified representative is strongly recommended to ensure your filing strategy aligns with all relevant national laws.
This is why a global mindset is not just beneficial—it is essential. Understanding the legal landscape across jurisdictions helps avoid missteps that could derail your patent strategy before it begins. A simple check of inventor nationality and residency should be standard practice when preparing any first filing.
Getting the first filing right is only the beginning. Much like an experienced globe-trotter double-checking their travel documents before crossing a border, the next critical step is to confirm you have all the right ownership paperwork in place before venturing further on your patent journey.
Securing patent rights isn’t just about filing the application—it’s about ensuring you actually own what you’re trying to protect. While many businesses assume that inventions created by employees automatically belong to the employer, this is not universally true. Ownership rules vary significantly between jurisdictions, and relying on assumptions can leave dangerous gaps in your portfolio.
In some countries, rights transfer to the employer under statute, by virtue of employment, provided the invention was made in the course of what the inventor, as employee, is paid to invent by their employer. In others, explicit written agreements are required to assign rights from the inventor to the company. Even where statutory provisions exist, they may not cover every scenario—such as contractors, consultants, or employees working outside their home jurisdiction. For instance, a British inventor seconded to Japan might be considered an employee under UK law, where rights default to the employer, but still retain initial ownership under Japanese law unless clear contractual assignment and compensation provisions are in place.
Failing to address these points early can lead to disputes, delays, or even loss of rights. For example, if an inventor refuses to sign an assignment after filing, you may find yourself unable to enforce the patent in certain countries and/or sell the patent. In India, for instance, the patent office will not proceed with examination until clear ownership is established through a written assignment from the inventor to the employer. It is worth noting that these rules are not set in stone. Just as a backpacker must keep up to date with the latest entry requirements to avoid being turned away at the border, it is essential to regularly review and update your IP agreements and processes to ensure your patent rights remain secure and enforceable wherever your innovation journey takes you. Laws and practices evolve, and what is sufficient in one jurisdiction today may change tomorrow.
The safest approach? Check your agreements before you file. Ensure employment contracts and consultancy agreements include robust IP clauses that take into account the laws of all relevant jurisdictions. Where necessary, execute separate assignment documents at the time of filing. This proactive step can save you from costly headaches later and keep your global strategy watertight.
With your essentials secured, it’s time to plan your route. A seasoned traveller knows that choosing the right path—whether it is a direct flight or a scenic detour—can save time, money, and a lot of unnecessary hassle.
When it comes to expanding your protection beyond the country of first filing, the route you choose can make a big difference in cost, timing, and complexity, notably with regards to formalities. For many applicants, the Patent Cooperation Treaty (PCT) offers a smart solution. It allows you to file a single international application and defer filings in individual countries (such as China) or regions (such as the European Patent Office) for up to at least 30 months from the date you filed your initial patent application.
The PCT route also helps centralise certain formalities. For example, if there’s a change in ownership or inventorship, you can record it with the World Intellectual Property Organization (WIPO)—the United Nations agency that administers the PCT—during the international phase. This avoids having to repeat the process in every national office—provided those offices recognise changes recorded with WIPO. This approach can be both more efficient and more cost-effective, reducing legal fees, translation costs, and the risk of inconsistent records across jurisdictions.
Even the best-planned itinerary can unravel if you lose track of your tickets or miss a connection. Likewise, as your patent portfolio grows, keeping every detail organised is what keeps your journey on track. From signatures and notarisation requirements to tracking deadlines and coordinating local agents, the administrative load can quickly become overwhelming—especially for large portfolios.
As your portfolio grows, so does the complexity of keeping every detail of the formal requirements (formalities) aligned. Each jurisdiction has its own rules, forms, and timelines—and the differences can be subtle but critical. Missing a signature, using the wrong form, or overlooking a local notarisation requirement can derail an application or even result in lost rights. Add to that the challenge of tracking annuity deadlines, coordinating national phase entries, and ensuring ownership and inventorship records remain consistent, and the administrative burden quickly multiplies.
This is where experienced, detail-oriented paralegals prove invaluable. They not only manage internal processes but also act as the hub between multiple local agents, gathering the necessary documents, signatures, and confirmations to keep everything on track. Their ability to coordinate across jurisdictions ensures that local requirements are met efficiently and accurately.
When your backpack starts to fill up, every extra item counts. Staying organised and making smart choices about what to carry can make the difference between a smooth trip and an exhausting trek. When formalities are managed proactively, organisations not only reduce the risk of lost rights or costly errors, but also gain the ability to respond quickly to market opportunities and allocate resources more effectively. In this way, efficient portfolio management becomes a genuine competitive advantage, helping businesses protect their innovations when and where they need to, enabling them to operate with confidence, and stay ahead in a fast-moving global landscape.
Building and maintaining a global patent portfolio is a significant investment, with costs arising from filings, translations, agent fees, and ongoing annuities. Yet, with careful planning and a strategic approach, many costs can be minimised. Centralised filings, careful checks to ensure alignment with local legal requirements, and coordinated assignments help prevent duplication and procedural errors, while strategic use of the PCT can defer expenses and provide valuable flexibility.
Think of our paralegals as the expert guides who know every shortcut, local custom, and hidden pitfall—making sure your journey is as smooth as possible, no matter how complex the route. Their expertise in managing intricate formalities, coordinating with local agents, and ensuring consistency across borders is vital to keeping costs down and portfolios secure. They proactively identify potential issues, manage deadlines, and facilitate smooth communication between all parties, ensuring that every detail is handled with precision.
At EIP, we combine strategic insight with hands-on expertise to help clients navigate the financial and procedural complexities of patenting all over the world. Our collaborative approach ensures your portfolio is protected and managed in a way that maximises both value and cost-effectiveness.
By Lucie Jones, Head of Client Services at EIP and seasoned backpacker
EIP shortlisted for The British Legal Awards 2025
We are proud to share that we've been shortlisted for The British Legal Awards 2025 in the newly introduced category: ‘IP Team of the Year’! A special shout-out to our fantastic Litigation team, whose exceptional work was instrumental in securing this recognition.
The British Legal Awards stand as the benchmark for excellence in the UK legal sector.
The winners will be announced at the award ceremony on Wednesday, 26 November 2025.
UPC Infringement Actions: Is Speed Meeting Expectations?
The preamble to the Rules of Procedure sets out the lofty aim that “proceedings shall be conducted in a way which will normally allow the final oral hearing on the issues of infringement and validity at first instance to take place within one year” [1]. This target appeared achievable based on the Rules of Procedure themselves, which set out time limits imposed on the parties at many of the stages of an action as well as some aims for when the court itself will take certain steps. Based on these parts of the Rules, we estimated that infringement proceedings would be dealt with in 10.5 - 13.5 months from service of the statement of claim, as shown in the expected timeline below. The length of the written procedure was expected to be shortest for infringement actions with no counterclaim for revocation and longest for those with a counterclaim and an application to amend.
Given that the preamble to the Rules of Procedure explicitly sets out the goal of having the final hearing take place within twelve months, this seems like a good place to start looking at how well the UPC is sticking to its promise of fast and efficient proceedings.
The UPC missed the 12-month target in 50% of cases, but it is close: 50% of cases were decided within 12 months and 5 days measured from service of the statement of claim [2].
The chart and table below show the time from service of the statement of claim to the final hearing for all of the 43 infringement actions decided up to 1 September 2025:
Time from service to final hearing / months (days)
Mean
SD
Min.
25%
50%
75%
Max.
No counterclaim
11.9 (361)
2.1 (65)
8.4 (256)
10.0 (305)
12.2 (370)
13.3 (405)
14.9 (454)
With counterclaim
12.5 (381)
2.3 (71)
8.1 (246)
10.8 (328)
12.2 (371)
14.0 (426)
17.3 (527)
All
12.4 (377)
2.3
(70)
8.1 (246)
10.7 (326)
12.2 (371)
13.9 (423)
17.3 (527)
Bearing in mind that this is a new court finding its feet, with many unclear procedural provisions requiring input from the Court of Appeal, it is promising that in 75% of cases the oral hearing was held within 14 months from service of the statement of claim.
Looking only at the time from service to the final hearing gives an incomplete picture. What really matters to claimants (and defendants) is the time required to reach the decision. A long delay in reaching a decision after the final hearing would undermine the effort required from both the UPC and the parties to get to the final hearing in roughly a year.
According to the Rules of Procedure, the court “shall give the decision on the merits as soon as possible after the closure of the oral hearing” and “shall endeavour to issue the decision on the merits in writing within six weeks of the oral hearing” [3].
So far, the UPC has managed to hit this six-week target in only 40% of cases, as illustrated by the chart and table below:
Time from final hearing to decision / weeks (days)
Mean
SD
Min.
25%
50%
75%
Max.
No counterclaim
7.9 (55)
6.3 (44)
2.3 (16)
5.6 (39)
6.0 (42)
6.0 (42)
24.3 (170)
With counterclaim
7.4 (52)
4.3 (30)
0.0 (0)
6.0 (42)
7.0 (49)
8.0 (56)
26.6 (186)
All
7.5 (53)
4.7 (33)
(0)
6.0 (42)
7.0 (49)
8.0 (56)
26.6 (186)
However, the delay is not severe, with 75% of decisions issued within 8 weeks of the hearing, and the cluster of decisions issued exactly 6 weeks from the hearing, visible as the points falling on the dashed line in the chart above, indicate that the UPC is generally trying to meet this target.
Furthermore, the extreme outliers at close to six months from the hearing to the decision result form the unique circumstances of the cases in question. For example, in one of the outliers[4], oral proceedings were held in a co-pending EPO opposition the day after the final hearing at the UPC, and the court delayed its decision in order to take into account developments in the EPO case.
Putting these two time periods together, the total time from service to decision across the 43 decided infringement actions breaks down as follows:
Time from service to decision / months (days)
Mean
SD
Min.
25%
50%
75%
Max.
No counterclaim
13.7 (416)
2.4 (74)
11.0 (335)
11.5 (351)
13.3 (406)
15.3 (466)
18.0 (549)
With counterclaim
14.2 (433)
2.4 (74)
9.9 (301)
12.3 (375)
14.0 (427)
15.6 (475)
19.8 (603)
All
14.1 (429)
2.4 (73)
9.9 (301)
12.2 (372)
14.0 (427)
15.6 (474)
19.8 (603)
Despite not straying too far from the individual 12-month and 6-week targets discussed above, the chart above clearly shows that the original estimate of 10.5 to 13.5 months (shown with grey-shaded area of the chart above) was overly optimistic. The clear majority of cases fall outside this time range, with only one outlier falling below the lower bound. Based on the available data, it would be more accurate to state that the typical range is 11.7 to 16.5 months[5] (shown in the green-shaded area of the chart above).
The longer-than-expected timeline for service to final decision raises the question: where are the assumptions made in the preparation of the original estimate holding up, and where are they being proven wrong?
It helps to first separately consider the cases in which a counterclaim for revocation was filed and those where a counterclaim was not filed .
The mean length from service to decision for actions without a counterclaim is around 3 months longer than expected at 13.7 months compared to the estimated 10.5 months. For actions with a counterclaim, the difference between the mean and the expected duration is less than 1 month.
While the mean time from hearing to decision is slightly longer for actions with no counterclaim than those with a counterclaim, it is clear from the chart above that the time from hearing to decision is, in general, shorter for actions with no counterclaim, with 80% hitting the 6-week target. This is understandable, since it’s much easier to decide and ultimately write a decision only on infringement than on both infringement and validity.
This suggests that of the three stages that make up an infringement action—the written, interim, and oral “procedures”—it is the written and/or interim procedure where the earlier assumptions are breaking down.
The six- to nine-month estimate for the written procedure was ostensibly the most reliable of the original estimates since it is based on hard deadlines imposed on the parties by the Rules or Procedure. However, the data show that this six- to nine-month estimate is, so far, quite far from reality:
Length of written procedure / months (days)
Mean
SD
Min.
25%
50%
75%
Max.
No counterclaim
9.5 (290)
2.0 (61)
7.1 (217)
8.2 (249)
9.3 (282)
11.0 (335)
13.1 (397)
With counterclaim
11.2 (340)
2.3 (70)
7.3 (222)
9.5 (288)
10.5 (319)
13.0 (396)
15.5 (471)
All
10.8 (328)
2.3 (71)
7.1 (217)
9.3 (282)
10.3 (312)
12.6 (382)
15.5 (471)
This suggests that a few assumptions that the original estimates relied on were incorrect. These assumptions include:
Assumption 1 has turned out to be simply false. In the majority of cases there is a significant gap between the filing of the final written submissions specified in the Rules of Procedure[7] and the closure of the written procedure:
It should be noted that many cases with a counterclaim for revocation include an application to amend the patent, and therefore may include an additional written submission on month later than the date shown in the chart above. Nevertheless, many cases, including those with no counterclaim and therefore no application to amend, include a significant delay between the date of the final written submissions and the closure of the written procedure.
One possible explanation for this delay is that the Rules of Procedure don't specify when the written procedure should end. This is the one part of the overall timeline that is entirely within the UPC's control but does not have a specified or target duration. Perhaps it is being used by the local divisions to give themselves some breathing room without impacting their ability to hit the target for the interim procedure.
Assumption 2 seems to be at least partially holding true. Parties appear to be making the most of the short time periods for reply provided for in the Rules of Procedure. However, the time from service to the final written submission is in many cases longer than would be expected based on the deadlines set out in the Rules of Procedure:
In infringement actions with no counterclaim for revocation, the maximum time envisaged by the Rules of Procedure between service of the statement of claim and filing the final written submissions is six months[8]. In an infringement action with a counterclaim, the maximum time envisaged by the Rules of Procedure is eight months[9]. While there are clear clusters of cases around the six- and eight-month lines in the chart above, in most cases the final written submission is filed significantly later than the theoretical "maximum". Without access to the pleadings in each case, it's difficult to say why the maximum was exceeded, but it is likely due to procedural issues such as changing the language of proceedings, which may result in some deadlines being re-set.
Assumption 3 is at least anecdotally holding true. Again, getting precise data on this from the CMS is not straightforward, but the general trend in published decisions and orders seems to be a strict approach to allowing further written submissions beyond those provided for in the Rules of Procedure.
According to the Rules of Procedure, the interim procedure should end no more than three months after the end of the written procedure[10]. As can be seen below, this target has been met or exceeded in almost every case so far.
Length of interim procedure / months (days)
Mean
SD
Min.
25%
50%
75%
Max.
No counterclaim
1.4 (42)
1.2 (38)
0.0
(0)
0.7 (22)
1.2 (38)
1.8 (54)
4.3 (132)
With counterclaim
1.2 (37)
1.2 (36)
0.0
(0)
0.4 (11)
1.0 (31)
1.9 (58)
5.7 (172)
All
1.2
(38)
1.2
(36)
0.0
(0)
0.4
(12)
1.1
(33)
1.9
(58)
5.7
(172)
The efficiency of the interim procedure compared to the originally estimated 3 months makes up for much of the slowdown in the written procedure discussed above. As expected, the length of the interim procedure does not seem to be significantly affected by the filing of a counterclaim for revocation.
In most cases the interim procedure includes an interim conference, the aim of which is to identify the main issues and relevant facts that are in dispute and set a date for the hearing, amongst other things[11]. However, in some cases an interim conference is not held, which may significantly shorten the interim procedure.
As explained below, the end dates of the interim procedure shown in the CMS for some of the cases are manifestly incorrect. The outlier shown in the chart above at 172 days is one of those points. Furthermore, the cluster of cases close to zero suggests that the UPC has not been entirely consistent in its approach to the transition from written to interim procedure[12]. Indeed, in some cases it appears that someone at the UPC may have forgotten to officially close the written and/or interim procedures until a couple of days before the scheduled oral hearing.
The Rules of Procedure state that the oral procedure begins "[a]s soon as the judge-rapporteur considers that the state of preparation of the file is adequate" or on the last deadline for a party to take some action set during the interim procedure[13]. This already suggests that the beginning of the oral procedure will not coincide with the oral hearing, so the assumption that the length of the oral procedure would correspond to the targeted six weeks from hearing to decision was already shaky. Indeed, as can be seen below, in a clear majority of cases, the oral procedure lasts longer than the assumed six weeks:
Length of oral procedure / month (days)
Mean
SD
Min.
25%
50%
75%
Max.
No counterclaim
2.8 (85)
2.1 (63)
0.7 (21)
1.5 (47)
2.0 (61)
3.8 (115)
7.7 (233)
With counterclaim
1.8 (56)
1.3 (41)
0.0
(0)
1.4 (43)
1.8 (54)
2.3 (70)
7.3 (222)
All
2.1 (63)
1.6 (48)
0.0
(0)
1.4 (44)
1.8 (56)
2.3 (70)
7.7 (233)
There is a cluster in the data with an oral procedure length of 0-5 days. In all of these cases, the date of the oral hearing listed in the UPC calendar is significantly before the date of closure of the interim procedure as indicated in the CMS. It's not clear what has gone wrong here—again, perhaps the relevant LDs simply forgot to formally end the interim procedure. In any event, in most cases the biggest factor affecting the length of the oral procedure is the time period between the oral hearing and issuance of the decision, as discussed in more detail above.
The time required for service of the statement of claim on the defendant is generally not within the control of the court, but it is still useful to understand what the typical timeline is. We can talk about the timeline from service to the final decision as much as we like, but the reality is that filing the statement of claim is the real starting gun, at least for the claimant. If the typical time required for service is too variable, then the hard work required from both the court and the parties to reaching the final oral hearing in the targeted 12 months will be undermined.
Length of service
/ weeks (days)
Mean
SD
Min.
25%
50%
75%
Max.
All
3.3 (23)
3.7 (26)
0.0
(0)
0.4
(3)
2.4 (17)
4.3 (30)
19.0
(133)
We have already seen that service outside the UPC contracting member states can be challenging, especially in China. Fortunately, with more than 50% of claims served within three weeks, service is not turning into a major bottleneck in most cases.
Given the significant differences in workload at the different local and regional divisions, it might be expected that the progress of cases at the busiest divisions would be slower. Furthermore, we have heard repeatedly that the German local divisions have difficulty composing panels of German-speaking judges for actions filed in German. Nevertheless, the differences between divisions do not appear to be significant, as shown below.
Service to decision / months
Count
Mean
SD
Min.
25%
50%
75%
Max.
Brussels (BE) Local Division
1
14.0
-
14.0
14.0
14.0
14.0
14.0
Düsseldorf (DE) Local Division
12
13.8
2.1
9.9
12.3
14.4
15.3
17.4
Hamburg (DE) Local Division
3
14.2
5.0
10.6
11.4
12.2
16.0
19.8
Mannheim (DE) Local Division
7
14.7
2.8
11.0
12.6
15.0
17.1
17.5
Milan (IT) Local Division
1
15.6
-
15.6
15.6
15.6
15.6
15.6
Munich (DE) Local Division
10
13.3
2.0
10.5
11.6
13.6
15.1
15.8
Nordic Baltic Regional Division
2
18.4
0.5
18.0
18.2
18.4
18.6
18.8
Paris (FR) Local Division
4
13.8
1.7
12.6
12.6
13.1
14.3
16.3
The Hague (NL) Local Division
3
13.7
1.5
12.3
12.9
13.5
14.4
15.3
Given the very small sample sizes for many of the divisions, these statistics need to be taken with a large pinch of salt. However, it’s clear that the German local divisions are not yet slowing down under their large workloads.
While the UPC is not quite hitting the specific targets of holding the final oral hearing with a year or issuing the decision within six weeks of the oral hearing in the majority of cases, it is coming very close. Some of the assumptions that were made before the court started operating have turned out to be false, but these have not led to a very large difference in the overall time from service to the final decision. And despite missing these targets, it’s fair to say that the UPC is still providing a fast and efficient process in first instance infringement actions.
[1] Preamble 7 RoP.
[2] While the preamble to the RoP doesn’t say “within one year of service”, this can only be what was meant. In many cases, especially those that rely on the Hague Convention for effecting service on defendants domiciled outside the UPC contracting member states, the length of time from filing the statement of claim with the UPC and the date of service is unpredictable and very much out of the court’s hands.
[3] Rule 118.6 RoP.
[4] Edwards v. Meril, UPC_CFI_380/2023, as we reported here: https://eip.com/uk/latest/article/edwards-v-meril-the-interaction-of-parallel-upc-and-epo-proceedings/
[5] Based on the mean (14.1 months) ± one standard deviation (2.4 months), which covers 2/3 of the sample.
[6] Unfortunately, applications to amend the patent do not appear in the list of cases related to the main infringement action in the old UPC CMS, so it isn’t straightforward to further classify the actions with a counterclaim into those with an application to amend and those without. This seems to be due to a glitch in the old CMS, which doesn’t reliably create the workflows for applications to amend in an infringement action with a counterclaim for revocation.
[7] These are i) the Statement of Claim, ii) the Statement of Defence, iii) Reply to the Statement of Defence, and iv) Rejoinder to the Reply. This chain of four submissions, two from each party, apply in each of the infringement action, the possible counterclaim for revocation, and the possible application to amend the patent.
[8] Statement of defence (3 months from service), reply to the statement of defence (+2 months), rejoinder to the reply to the statement of defence (+1 month).
[9] Statement of claim in the revocation action (3 months from service), defence to the counterclaim (+2 months), reply to the defence to the counterclaim (+2 months), rejoinder to the reply (+1 month). Note that the date of final written submissions for actions with a counterclaim in the chart is the date of the rejoinder to the reply to the defence to the counterclaim, so the potential missing month for a rejoinder in a possible application to amend is not relevant.
[10] Rule 101.3 RoP: "[w]ithout prejudice to the principle of proportionality, the judge-rapporteur shall complete the interim procedure within three months of the closure of the written procedure" (R101.3).
[11] For a full list, see Rule 104 RoP, which sets out the “aim of the interim conference”.
[12] For example, in ACT_19746/2024 (UPC_CFI_173/2024), the written procedure and interim procedure were closed on the same day, 3 days before the oral hearing.
[13] Rule 110 RoP
Does an ongoing phase 3 clinical trial and its published protocol suggest that the tested drug will be successful?
A recent EPO Boards of Appeal decision, T 0136/24, has examined the issue of “reasonable expectation of success” when the prior art discloses a protocol to an ongoing phase 3 clinical trial. How much weight should be given to such protocols when the outcome of the trial had yet to be published?
The patent of interest claimed a new anti-cancer drug, cabazitaxel, for use in treating a specific type of prostate cancer in patients who had previously undergone alternative therapy. The Opponents argued that the authorisation of a phase 3 trial necessarily implied that cabazitaxel had demonstrated success in previous clinical trials and preclinical models. Additionally, the Opponents alleged that as the trial was nearing completion at the patent’s priority date, this indicated that the trial had not been terminated prematurely due to poor results. Thus, the Opponents sought to put the burden of proof on the patentee, arguing that the use of cabazitaxel in this patient group should be deemed inventive only if there was any information plausibly contradicting a baseline expectation of success.
The Board rejected these arguments, stating that the specific context must be considered. Here, only a single patient with the appropriate type of prostate cancer was included in the relevant phase 1 trial. Cabazitaxel for use in prostate cancer then proceeded immediately to phase 3 trials and therefore no phase 2 trial results were available. Finally, the mere fact that a clinical trial was nearing completion was deemed to reveal nothing without published details of interim reviews.
An ongoing phase 3 clinical trial and its published protocol should not necessarily result in a reasonable expectation that the tested drug will be successful. Instead, one must consider the specific circumstances, such as what prior trials had actually tested and demonstrated, and how much was known about the drug’s clinical efficacy and safety profile in the relevant therapeutic indication.