This year BOEHMERT & BOEHMERT will once more be organising the intensive workshop, “Obtaining, Enforcing and Evaluating Intellectual Property Rights in Europe”. It will take place between 30th June to 09th July in Munich, divided into two parts – patent law and trademark law. Content, workshop program and registration papers are available to download here (as pdf file in English).
BOEHMERT & BOEHMERT partner Prof. Dr. Heinz Goddar was again listed in the “Who’s Who Legal: Patents 2016” as among the most important patent lawyers. The print edition of the yearbook will appear in April 2016; the online version can be accessed via www.whoswholegal.com and brings together around 17,000 specialists in 36 legal fields across the globe. In the field of IP, the yearbook limits its attention to just 321 leading names.
The 8th German edition of the originally American publication Best Lawyers has just been published by Handelsblatt. Here, BOEHMERT & BOEHMERT has been selected as Law Firm of the Year in the field of Industrial Property Protection. The partner Dr. Ludwig Kouker (Bremen; Industrial Property Protection) was named as “Lawyer of the Year 2016“ in the named legal field.
BOEHMERT & BOEHMERT is also represented this year with a total of ten lawyers and three offices. At the Munich office, the following lawyers are named: Christian W. Appelt (IP), Dr. Markus Engelhard (IP), Prof. Dr. Heinz Goddar (IP). At the Berlin office, the following lawyers are mentioned: Dr. Ute Kilger (Health Care/Biotech) and Dr. Martin Schaefer (Media Law, Copyright). At the Bremen office, Dr Ludwig Kouker (IP) and Malte Nentwig (IP) are mentioned. The rankings of law firms and lawyers are based on assessments by colleagues from other firms in a peer-to-peer procedure, which provides especially reliable results. Best Lawyers is therefore considered one of the most respectable legal rankings. The current Best Lawyers ranking for Germany spans 857 lawyers working in 220 law firms.
As part of its Annual Awards, Global Law Experts has presented BOEHMERT & BOEHMERT with two awards, with the firm being recognised as the “IP Rights Enforcement Law Firm of the Year in Germany – 2016” and the “Trademark Protection Law Firm of the Year in Germany – 2016”. Global Law Experts identifies as an international online database of businesses and consultants in legal and financial enterprise. Since 2010, Global Law Experts has presented its Annual Awards in various legal fields to businesses in recognition of exceptional performance.
The current issue of “Chambers Global 2016” counts BOEHMERT & BOEHMERT among the leading firms in “Patent Prosecution”, with the firm also once again being ranked first this year (Band 1). Prof. Dr. Heinz Goddar (“remains well respected for his vast experience in patent prosecution”) and Dr. Steffen Schmidt were named in particular. “Chambers Global” highlighted the following: “What the team is known for: Demonstrates close collaboration with its offices, offering seamless cross-border solutions. Market-leading patent prosecution department and strong presence in patent litigation in several sectors, most notably biotech.“
“Chambers Global” provides a global perspective of recommended firms in various legal fields. BOEHMERT & BOEHMERT has received particular recognition for years in the category of “Intellectual Property – Germany”, among others for “Trade Mark & Unfair Competition”.
In the now fifth edition of “IAM Patent 1000 2016 – The World´s Leading Patent Practitioners”, BOEHMERT & BOEHMERT has held on to its “highly recommended” ranking in the “Patent Infringement” category while being awarded a recommended ranking in the “Transactions” category. BOEHMERT & BOEHMERT’s partners and patent law specialists Prof. Dr. H. Goddar, Christian W. Appelt and Dr. M. Engelhard, will also be highlighted this year as recommended “individuals”. A new addition is Dr. M. Rüberg, who will also be among the recommended “individuals”. Prof. Goddar is again listed as a “luminary” at the very top of the ranking list. According to the overall assessment, “BOEHMERT & BOEHMERT remains one of the pre-eminent names on the non-contentious IP scene. The firm files close to 4,000 patent applications annually with the EPO, DPMA and foreign patent offices on behalf of everything from start-ups to mid-size companies and multinationals. It also maintains a robust contentious arm, making it a persuasive option for one-stop shopping. Having spent time undertaking postdoctoral research in the University of Cambridge’s biochemistry department, Markus Engelhard is a technical mastermind who can astutely advise research institutions and government bodies on even the most esoteric matters. Munich-based Heinz Goddar is a former president of the Licensing Executives Society International; an authority on patent and licensing law, he frequently lectures on the subject. “Fantastic practitioner” Michael Rüberg has extensive in-house experience and specialises in IP portfolio management. With Osaka and Tokyo familiar terrain for him, Christian Appelt is a lodestar for Japanese clients.“ The full ranking is here
In the latest edition of the “IP Stars Handbook 2016” from Managing Intellectual Property, BOEHMERT & BOEHMERT is well-represented in three categories. The publisher has now also published the names of the individual partners. This year, a total of five BOEHMERT & BOEHMERT partners have been nominated as “IP Stars” amongst others: Peter Gross, Dr. Carl-Richard Haarmann and Dr. Volker Schmitz-Fohrmann. In Trademark Prosecution and Trademark Contentious, the office is at second place in each category, while in Copyright it holds first place. Managing Intellectual Property also quotes a client that refers to the “excellent, consistently great service and assistance” of BOEHMERT & BOEHMERT. The individual partners for the Patent Law segment will be nominated by name by the publisher in July 2016. The current listing can be viewed here.
On Thursday last week (23 June 2016), the UK voted to leave the EU, and thereby decided for what has become known as the “Brexit”. As of today, it is still uncertain what the exact implications of this decision are, including important questions such as when the UK will finally exit the EU, and what the political and legal nature of the future relationship between the UK and the EU will be like. As one of its member states exiting the EU is, obviously, an entirely unprecedented scenario, and as no statutory provisions or case-law point towards reliable answers, it is not sufficiently clear yet what effects the Brexit will have on the overall legal landscape, including the different types of Intellectual Property (IP) rights. The following, preliminary thoughts should therefore help to provide some guidance on navigating your IP rights through these challenging times:
First of all, and importantly, the Brexit vote, by and in itself, does not lead to any immediate legal consequences for your existing IP rights, nor for the grant of new IP rights in the near future.
While the vote is considered a political imperative, it is not a formal, legally binding trigger for the UK to exit the EU. Even though the UK government announced to accept the imperative of the vote, recent trends seem to reveal some strong resistance within the UK general public and members of the UK parliament against a continuation of the exit process.
Once (and if) the UK decides to continue the exit process, the Lisbon Treaty requires them to notify the European Council of their intention to withdraw. Prime Minister Cameron intends to do so later this year in October, whereas Council representatives already expressed expectations to receive such notification much sooner (within weeks).
Upon notice, there will be a two years’ term, jointly extendable, to negotiate a Withdrawal Agreement, containing a framework for the future relationship between the UK and the EU. Absent agreement until end of this term or unanimous term extension, all Union Treaties, rights and obligations would cease to apply in the UK. Such “cold exit” is, however, extremely unlikely to happen. As things stand, negotiations are likely to be entered into and wrapped up by 2019 at the latest, in time for the next elections to the European Parliament. However, while an intense political debate on this issue is ongoing, the exact timing and process for the UK’s exit remains speculation.
Before, and until a completion of the withdrawal process, the UK will continue to be a EU member state, so that, until then, the legal landscape for IP rights will remain largely unaffected. What the legal landscape for IP rights will ultimately look like after the UK’s exit will, to a large extent, also depend on the contents of the Withdrawal Agreement and further, bi-lateral agreements between the UK and individual EU member states. Also, it will be of importance whether the UK decides to join the European Economic Area (EEA), or not.
The existing (“old”) European system for Patent Rights should only be mildly affected by the UK’s exit, whereas one of the areas to be strongly affected is likely to be the current system for supplementary protection certificate (SPCs). The planned (“new”) European system of unitary patent rights and a Unified Patent Court (UPC), however, is likely to, at least, face significant delays:
The existing/old European system for patent rights is based on a centralized application process through the European Patent Office (EPO), in which the „European patent“ itself, after grant, is divided in and converted to its national parts (the so called „EP Bundle Patent“).
This centralized application process is based on an international treaty between the participating nations. It is neither based on EU law, nor is the EPO an EU institution. In fact, a number of the participating nations, also today, are not EU member states.
Given the benefits of this centralized application process, it is to be expected that the UK will continue to participate in this system, irrespective of the future nature of the UK/EU relationship. Thus, no substantial consequences are expected for the EP (Bundle) Patents.
One of the areas which may be affected immediately, however, i.e. even prior to the UK’s exit, is the upcoming/new Unitary Patent Court (UPC) system.
As reported in previous B&B Bulletins, the UPC, which is set to allow both for the EPO’s grant of one unitary patent for all participating EU member states, and the enforcement of all European patent rights in a new, unified European court system, has long been anticipated and, after multiple delays, was expected to finally arrive in 2017.
The underlying agreements, however, still lack necessary ratification by the UK, as the (formerly) third largest EU member state in terms of patent filing numbers. As the agreements require ratification by “the three Member States in which the highest number of European patents had effect in the year preceding the year in which the signature [took] place”, and as signature occurred in 2013, it seems somewhat unclear whether the UK’s ratification can simply be replaced with the fourth largest EU member state in terms of filing numbers (at that time, or today), or whether this will require a formal re-draft of the agreement to allow for this result. While the majority of commentators seem to call for a re-draft, it will also need to be determined who is the EU member state stepping in – with both Italy and The Netherlands seeming similarly eligible for this role (mostly depending on whether withdrawn patents are counted in when determining the filing numbers, or not).
Also, the UPC foresees that London will host a major part of the UPC’s infrastructure, namely the part of the so called “central division” responsible, inter alia, for the economically important pharma and life sciences litigation. While the agreements are, possibly by chance, drafted in a way to allow this central division to stay in London even without the UK being a part of the UPC, most commentators suggest that this would not make any sense for neither the UPC system nor the UK. If the central division needs to be moved away from London, however, another re-draft will be necessary (plus all logistical issues to be resolved).
One possible way to avoid at least some of the aforesaid would be for the UK to still ratify the agreements, prior to its exit. As there is little to be gained from doing so for the UK (as the UK could still not become a part of the UPC system, which is only open towards EU member states), and given the overall political and economical turmoil, however, it is doubtful that the UK will do so.
Thus, considering the aforesaid, and despite all optimism and efforts currently undertaken to “make it work”, it seems likely that there will be, again, at least a significant delay on the UPC’s coming into force (i.e. to a date later than 2017). If a relevant number of participating member states should be unwilling to participate in a UPC without the UK, or if the current political process in the EU should in fact lead back to stronger nationalism, the UPC project might also be endangered as a whole.
Whether is would be possible for the UK to still participate in the UPC as an “outsider”, by way of a multi-lateral agreement with all participating EU member states, seems highly uncertain and, given, both the legal nature of the underlying agreements and the current political will (“out is out”), as rather unlikely. If the UPC will therefore, eventually, come into force without the UK, it will obviously be a weaker system in that it will not extend to (what is still expected to remain) one of the major European economies. Thus, while the system might still be attractive for some patent owners, e.g. by virtue of its extension to the eastern European countries, there is also a significant chance that things in the patent world will, for a considerable time, go back to “usual practice”, i.e. national (including via the EPO centralized application process) filings and national, “exemplary” enforcement in major European jurisdictions, such as Germany, The Netherlands, or France.
SPCs are currently available to extend the life of a patent beyond the usual twenty years from the date of filing for certain, limited types of inventions (primarily pharmaceutical inventions). Since it is governed by EU regulations, the SPC regime in the UK will not automatically apply to allow the grant of SPCs after the UK’s exit from the EU.
Many non-EU member states have national SPC regimes (such as Switzerland), or have adhered to the EU SPC regime through their EEA membership (such as Norway and Iceland). Considering the importance of SPCs also to the UK economy, it seems likely that the UK will enter into similar arrangements. For SPCs that are in force at the time of the UK’s exit, however, transitional provisions will need to be established.
First of all, UK trademarks and International Registrations designating the United Kingdom will, in principle, continue unaffected.
Certainly, in future, the laws governing national trademarks may develop independently and to some extent, differently. This will then require trademark owners, together with counsel, to monitor another set of national statutes and common-law peculiarities. We will of course monitor these developments and give further guidance in due course.
In contrast, there will likely be a significant impact on European Union trademarks (EUTM) and International Registrations designating the European Union.
With the UK’s exit, supranational rights like the EUTM and international treaties like the Madrid Protocol governing International Registrations in the European Union will cease to have effect in the UK. The UK and EU will need to negotiate (and, given the mutual benefits, are likely do so) that EUTMs continue to have effect in the UK as national trademarks, with the same priority and seniority. Conversion, transformation or continuation of effect are means available and all of them have been seen in the past. UK owners of EUTMs would then remain entitled, but will require an attorney of record or address for service within the Union.
With International Registrations, things will be more complex. Under the Madrid Union regime, it will remain possible to designate the European Union on the basis of a UK trademark. But, it will become impossible for UK companies to have an International Registration on the basis of a EUTM. They do no longer have a commercial establishment in the European Union. This could potentially put at risk trademark portfolios that are home-based in the UK to extend across the European Union. International trademark owners following this approach are well-advised to thorougly consider this as soon as possible.
As of today, while the date of a possible exit is still uncertain, and while the advise how to best prepare for the aforesaid situation is still evolving, a risk adverse strategy could include
For purpose of monitoring conflicting trademarks, the UK should, already now, be treated as any other European country outside the Union. Similarly, a watch service for trademarks should extend to Europe instead of the European Union.
Oppositions based on UK trademarks at EUIPO will suffer a lethal defect upon the UK’s exit of the EU – such trademarks are then no longer suitable prior rights! Similar applies to those based on EUTM in the UK against national trademarks. The material point in time of validity is that of decision-making, not that of filing. The UK and EU will need to resolve this situation in their upcoming negotiations. In the interim, a review of options available to cure this likely defect in opposition proceedings is highly recommendable.
For Registered Community Designs, the same as for EUTMs will (have to) apply, so they are also likely to be strongly affected. Precautionary re-filings will not be possible outside the grace period of novelty.
Unlike the European Union, the United Kingdom did not become member to The Hague Agreement concerning industrial designs so that designs that currently extend via the EU designation may also face a similarly concerning situation.
For Unregistered Community Designs, the legal basis will be gone but UK laws know unregistered design rights protecting against copying of the design in the United Kingdom. The latter may become a recourse for those who lost the protection of registered designs due to Brexit.
There may be further consequences for other IP rights and the European IP regime, such as:
As copyright law in most EU member states, including the UK, is still strongly influenced by national legislation, copyright law should not be overly affected. Similarly the EU concept of database rights has been fully incorporated into UK law years ago, and may remain unaltered with only minor changes in its language (primarily to reflect for the new situation of the UK not being called a „EU member state“ anymore). All current and future harmonization efforts on an EU level, however, would not be automatically applicable in the UK, so greater scrutiny will be required as regards the national peculiarities of copyright and database right legislation.
Similar to the SPC regime, Plant Variety Rights in the UK are governed by EU regulations, so these rights would cease to exist after the UK’s exit from the EU. Also here, however, it is to be expected that the UK legislators will find an appropriate solution, either on a national or EEA route. As with SPCs, right owners who rely on these rights in the UK will need to pay special attention to transitional provisions and their future filing strategy.
With likely limitations on the free movement of goods (depending also of whether the UK joins the EEA) the question may occur whether and to what extent the existing regime on exhaustion of rights and border detention will be maintained, or whether there will again be customs detention of IP infringing goods at the “UK/EU border”. The strategic implications of these developments need to be assessed at a later stage, when more details become available.
While the UK’s exit from the EU is expected not to fundamentally change general licensing practices, future licensing agreements will need to account for this fact, and will need to include appropriate wording to reflect for both the changed geographical situation and the necessity for obtaining and observing national rights in the UK (as further outlined above). If not drafted in such open manner, it may already now be time to review and, possibly, even re-negotiate your contracts.
Obviously, for every type of IP, right holders cannot accept loopholes in protection and cannot simply wait for an undefined period of time. While not binding yet, the Brexit should – right now – cause IP owners to consider options and seek advice on how to move forward.
Boehmert & Boehmert is of course closely monitoring all of the aforesaid developments. All of our partners are available for follow-up questions and to discuss any of these or any related issues also in relation to your company’s individual IP portfolio.
The German Federal Patent Court refused to grant a Supplementary Protection Certificate (SPC) for aminosilane-coated iron oxide nanoparticles which were authorized for the European market as a medical device. Although the decision clearly refuses an analogous use of the SPC regulation for most medical devices – only the EU legislator could introduce a new medical device SPC – the court still leaves open whether at least implantable medical devices containing active pharmaceuticals might be subject of an SPC under the current regulations.
Supplementary Protection Certificates (SPCs) provide additional patent term for medicines or plant protection agents after the expiry of the basic patent. Since gaining approval to place a new medicament on the European market requires a cumbersome and time consuming administrative procedure, a large proportion of the standard 20 year patent term passes by without providing any benefit for the patent owner. With the regulation (EC) No. 469/2009 (“SPC regulation”) the European Union (EU)-legislator intended to compensate the loss in effective patent term and to allow companies to recoup their investment in clinical trials and administrative procedures. SPCs grant up to 5 additional years of patent protection for approved medicines or plant protection agents. Up to the present day many SPCs have been granted in Europe for medicinal products containing chemical compounds as active ingredients. Still unclear is, however, whether therapeutic medical devices, or devices containing therapeutically active ingredients, can also be subject of an SPC.
The market authorization procedure for medical devices is regulated in Directive 93/42/EEC and Directive 90/385/EEC (the latter for active implantable medical devices), whereas medicines are approved according to Directive 2001/83/EC. Although approval of medical devices, in particular if they are implantable and contain pharmacological active ingredients, also involves extensive preclinical and clinical testing, the authorization procedure is not identical to medicines. For example the responsible institutions for granting a market approval for medicines are public institutions such as the European Medicines Agency (EMA), whereas medical devices are approved by specialized qualified private organizations.
The German Federal Patent Court now decided on an appeal filed by an applicant for an SPC for the medical device “aminosilane-coated iron oxide nanoparticles” (case no. 14W (pat) 45/12). The SPC was filed on basis of the European patent EP 0 636 111 and an EC design examination certificate as first market authorization granted for the product NanoTherm AS1. The German Patent Office had previously rejected the SPC application with the argument that the nanoparticles are not a medicinal product in the sense of Article 1 of the SPC regulation, but a medical device according to EU Directive 93/42/ECC. In appeal proceedings the applicant explained that although the nanoparticles are a medical device, they are likewise a medicinal product according to the SPC regulation as they provide a therapeutic effect. The appellant further stated that the EC design examination involved extensive clinical testing which lasted for about 11 years until the product could be placed on the market. The patent owner thus suffered from a loss of effective patent term comparable to the situation of innovative medicines, and that therefore an analogous application of the SPC regulation for medical devices is justified.
The 14th senate of the German Federal Patent Court in the decision 14 W (pat) 45/12 did not share the view of the applicant. With reference to the recent decision of the Court of Justice of the EU (CJEU) in Forsgren (C-631/13 dated 15 January 2015) the senate argued that SPCs may only be granted for medicinal products containing an active ingredient or combination of active ingredients with own pharmacological, immunological or metabolic effects. Thus the senate analyzed the question whether the nanoparticles have a pharmacological, immunological or metabolic effect on their own. During a cancer therapy the nanoparticles are administered to cancerous tissue in a patient and then activated by applying an alternating electromagnetic field which induces heat locally at the targeted site to destroy or weaken tumor tissue. The therapeutic effect of the nanoparticles is therefore produced solely by physical means and is not of a pharmacological, immunological or metabolic nature.
Following the senate’s understanding of the CJEU decision in Forsgren with respect to the interpretation of the term “active ingredient” in Article 1b of the SPC regulation, the patent court’s negative decision is probably not very surprising. Interesting is, however, that the judges still comment on the possibility of an analogous application of the SPC regulation for medical devices. The judges specifically deny analogy for “medical devices that do not contain an active ingredient in the sense of regulation (EC) No. 469/2009” (emphasis added). Applying the SPC regulation to medical devices would constitute an inadmissible expansion of the scope of the regulation. Although the judges agree with the applicant’s argument that the marketing of medical devices requires extensive clinical testing, only the European legislator and not the courts could provide relief to the unsatisfactory situation. The senate indicates that the legal SPC framework does not exclude additional regulations allowing SPCs for medical devices.
Here the 14th senate specifically rejected an analogous use of the SPC regulation for medical devices without active ingredients. The question thus remains whether there is a possibility for an analogous use of the SPC regulation for a medical device containing an active ingredient. But even if the question could be answered in the affirmative, there is unfortunately another hurdle in Article 2 of the SPC regulation. Market authorizations for medical devices are exclusively granted under the European medical device directive and not via the administrative procedures for the authorization of medicines under EU directives 2001/83 and 2001/82. In the case Hylan A and Hylan B (15 W (pat) 28/08) the 15th senate of the German Federal Patent Court previously rejected an SPC for a medical device on the ground that Article 2 of the SPC regulation would require a market authorization by an “administrative” procedure, which the senate did not recognize in the procedures for the authorization under the medical device directive. As mentioned before, it is currently mandatory to apply for market authorization for a medical device under the medical device directive and thus the Hylan A and Hylan B decision shuts the door for any analogous use of the SPC regulation for medical devices. Although the case was open to a legal revision by the Federal Supreme Court, the applicant did not file an appeal.
Contrary thereto, other European courts granted SPCs to medical devices containing active ingredients in the past. The Dutch court in the case Genzym vs. Bureau voor de Industriele Eigendom decided that an analogy between the procedures for market authorization for active implantable medical devices and medicines is fully justified. Even the 14th senate of the German Federal Patent Court – then in a different composition – granted an SPC in the case Yttrium-90 glass microspheres (14 W (pat) 12/07) on the basis of an authorization pursuant to the medical device directives. Obviously the national case law is not harmonized and one may hope that this question will finally find its way up to the CJEU for a clarification whether active implantable medical devices can be subject of an SPC under the current regulations.
In a recent decision, the Technical Board of Appeal of the European Patent Office ruled that Swiss-type claims pertaining to the use of a known medicament in the treatment of a further disease cannot be changed to Compound-for-Use claims.
The original European Patent Convention (EPC) from 1977 did not contain a specific regulation for inventions pertaining to the use of a known medicament in the treatment of a further disease (second medical indication). To fill this gap in the EPC the Enlarged Board of Appeal in their decision G 3/85 introduced by legal fiction the possibility to obtain a patent for a second medical indication using the so called Swiss-Type claim, which is drafted in the form: “use of a compound x in the manufacture of a medicament for the treatment of disease y”. Since the revision of the EPC in 2007, Article 54(5) EPC explicitly allows claims to second medical indications when using the claim wording: “compound x for use in the treatment of disease y” (Compound-For-Use claim). There was much debate in the field about whether Swiss-Type claims and the new Compound-For-Use claim for second medical indications confer an identical or a different scope of protection. In previous decisions regarding the problem of double-patenting the Technical Board of Appeal (TBoA) indicated that the scope of both claim formats are most likely not identical, because it is an established understanding that method and use claims have a smaller scope compared to product claims – a fairly cursory analysis of this question.
Now in the decision T 1673/11 the TBoA decided a case where a patent proprietor during opposition proceedings amended the granted claims by changing from Swiss-Type to Compound-For-Use claims, while maintaining all remaining claim features with respect to the compound and the medical indication. Whereas the opposition division allowed the amendment and maintained the patent in amended form, the TBoA decided that a change of claim format in the direction Swiss-Type to Compound-For-Use constitutes an inadmissible extension of scope of protection of a patent according to Article 123(3) EPC. The patent was revoked.
The outcome is not overly surprising, since in previous cases the TBoA indicated that there indeed is a difference in scope of protection between Swiss-Type claims and Compound-For-Use claims. However, the exact nature of this difference was not discussed until today. Under item 9.4 of the decision the Board reasoned that a so called off-label use of a packaged medicament in a patented indication falls under the scope of protection of a Compound-For-Use claim, while a Swiss-Type claim would not cover such a use. Whether this analysis will be reiterated in national infringement courts or in the upcoming Unified Patent Court is questionable. There are already national court decisions which analyse the issue of off-label or skinny-label uses differently and with more appreciation for the complexity of the problem (LG Hamburg 327 O 67/15; Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 72 (Pat)).
Nevertheless, the decision underlines that applicants for European patents more than ever should include Compound-For-Use claims during examination proceedings in their claim sets to protect their second medical indication invention exhaustively. A later conversion from the Swiss-Type format to Compound-For-Use during opposition or limitation proceedings is not possible at the EPO.
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