The medical technology (MedTech) sector is vast and complex, with companies large and small supplying and developing an enormous array of different products and services from the surgical instruments and capital equipment used in operating theatres; laboratory and point-of-care diagnostic systems; paraphernalia and accessories for doctors and patients to prepare and administer medicines; active and passive implants for musculoskeletal, pulmonary and neurovascular systems; and data-driven connected devices for monitoring and enhancing patient care. The innovation and associated legal issues spread far and wide, requiring IP strategies that work across devices, systems and data processes that are involved in every aspect of the European healthcare markets.
MedTech is a valuable sector in Europe – estimated at €150 billion in 2021 (eclipsed only by the US), having grown by an average of 4.8% per year over the past 10 years. Underpinning that value is an enormous quantity of IP. In 2022, over 15,500 European patent applications were filed in fields related to MedTech. According to EPO statistics, the sector represents 8.1% of all European applications and 7.9% of European patents granted in 2022. Current trends towards personalised medicine, patient-led treatment, preventative interventions and automated diagnoses that often arise from seemingly ubiquitous collection and analysis of data suggests that innovation and IP in MedTech is only likely to increase in the years to come. This says nothing of the rise in surgical robotics and software, which was covered in our previous article in this series.
Unlike the pharmaceuticals sector (covered by the first article in this series), patent coverage in Europe across the MedTech sector is frequently patchy. One reason for this is that historically the cost of a pan-European patent validation strategy can be prohibitive for small MedTech companies, and arguably even more so for large ones that obtain several hundreds of new patents each year. It will be interesting to keep a close eye on whether this problem persists, as the new Unitary Patent (UP) eventually replaces many MedTech companies’ ‘conventional’ validation strategies. Early indicators suggest that take up of this new right has been very popular in the sector. Even so, MedTech companies will for some time to come be dealing with a patchwork of European patent rights, both from an enforcement and FTO standpoint, which bring particular challenges for enforcement and defensive strategies.
Historically, the cause (as well as the effect) of this landscape in MedTech is that simultaneous patent enforcement across a very large number of European countries is rare. Over time, this has led to a concentration of IP rights in certain jurisdictions. Typically, companies have chosen to prioritise countries that not only include the largest end-user markets for MedTech products (i.e. Germany, France, UK, Italy), but also those that are key to the continuity of a supply chain (e.g. Switzerland, especially for drug delivery devices), those where manufacturing takes place (e.g. Ireland, whose favourable tax regime has attracted many multinational companies to establish their European manufacturing hubs there, along with Poland), those where infringing goods from outside of the European market tend to enter it (e.g. the major gateways of Belgium and the Netherlands), and those where Europe’s extensive list of MedTech trade shows happen (predominantly Germany, but also Spain, Switzerland, the UK and those which move from country to country each year).
Of course, this patchwork has long informed defensive and enforcement strategies in Europe, including the filing of protective letters, where they have been available, and decisions on whether and where to file for preliminary injunctions, given the historic variation in practice in the national courts. The question is, what’s new with the UPC? Though an original objective of the court was to harmonise and simplify aspects of European patent litigation (in the hope that this would reduce costs for litigants), the nature of the countries listed above demonstrate it was never going to be that simple in the MedTech sector, or at least not at first. Whilst some of the established key markets (Germany, France, Italy, Belgium, Netherlands) are currently part of the new system, Ireland still requires a referendum before it can join the UPC. The UK, Switzerland, Spain and Poland are either unable to or have no current plans to participate. This leaves decision-makers in MedTech companies with a very difficult situation to navigate.
As discussed in our introductory article, there are many considerations when it comes to use of the UPC, and of course the right approach will be fact specific. This article does not go into detail on validation or opt-out strategies, since previous articles have covered this. Instead, this article aims to build on the other articles in this series by focussing on three aspects that will be high on the list of concerns for MedTech companies, given the landscape described above: i) whether the UPC is the right forum or not to bring litigation; ii) whether the UPC is as reliable a court as the national jurisdictions for applications for preliminary injunctions; and iii) what implications the UPC has for FTO and clearing the way.
Scenario 1 – Forum choice; to use the UPC or not?
Your MedTech company has a granted European patent covering a MedTech device, which has been validated nationally in some of the “major” MedTech states and a mixture of other EPC states. You are aware of competitor activity by ComPete in states where the European patent is validated, including in UPC and non-UPC states, as well as more broadly across Europe. You want to be awarded final injunctions for ComPete‘s actions in as many jurisdictions as possible, and quickly.
Let’s first consider the available options, supposing ComPete is based in a UPC state such as Germany.
Should I choose to start litigation in the UPC?
As ComPete is acting in more than one UPC state where the patent has been validated, a single infringement action may be brought at a single UPC local or regional division to seek an injunction across multiple UPC territories. To date, we have seen infringement actions brought at the UPC, with 40% of those brought at the Munich local division, from applicants looking to make use of the speed of the new court. First instance hearings are expected to be held within 12 months, with final written decisions following within approximately two months. Any final injunctions that are won would directly cover any infringing acts taking place in any UPC state in which the patent is validated. In our scenario, this would include the state in which ComPete is based, and any validated UPC state in which ComPete is performing an infringing act.
However, it may be possible to go even further. Because ComPete is based in a UPC state, the UPC’s “long-arm jurisdiction“ means that decisions from the UPC could be further reaching. A judgment of infringement given by the UPC against ComPete will also be recognised in all EU member states in which the patent takes effect, by virtue of the . The Brussels Regulation could also extend the reach of certain remedies to those validated, EU member states. It is likely that such a judgment would also be recognised by non-EU signatory states of the Lugano Convention (Iceland, Norway and Switzerland).
By choosing the UPC for enforcement, therefore, not only could you assert your patent in the UPC states in which it is validated, but it might also be possible to stop ComPete or seek remedies/damages in respect of its activities in non-UPC, validated states as well as all EPC states where the patent is validated (for example, including Spain, Switzerland, Poland, and Hungary).
The reach of the long-arm jurisdiction is yet to be established. However, a single UPC action stemming from a patent validated in the relevant markets would likely restrict the options available for a UPC-based competitor to use alternative land routes or ports, switch manufacturing locations, or exhibit at various trade shows across the EU. Of course, the Brussels Regulation does not extend the UPC’s jurisdiction to states in which the patent has not been validated. This means that, going forward, savings made from use of UPs could be spent on validation in EU, non-UPC territories (such as Poland and Spain) that wouldn’t otherwise make the cut, given the potential for the use of the Brussels Regulation or Lugano Convention to force decisions from the UPC to be recognised in those jurisdictions.
Should I choose to start litigation in the national courts of UPC states?
National actions would need to be brought against each competitor in each relevant jurisdiction. Any injunction that doesn’t rely on the Brussels Regulation or the Lugano Convention would apply only to the state in which it is granted and so would not protect against your competitors moving, e.g. their importation activity to another state or exhibiting at a trade show in a different jurisdiction.
National actions in UPC participating member states can also affect the future competence of the UPC in the same patent so, going forward, you could be precluded from going after infringers centrally in all validated UPC states. Your options for enforcing your patent rights in the future may then be limited to the national courts. This might weigh against litigation in the national courts of UPC states, particularly if you are aware of other potential competitors you may want to enforce your patent against in the future and especially if the patent has considerable term remaining, and should factor into any opt-out strategy.
Regardless of the forum in which you launch your infringement action, you might expect ComPete to respond with a claim for invalidity of your patent. As patentee seeking to disrupt the infringer’s activities, having the patent outside of the UPC’s jurisdiction could provide some advantage. Some jurisdictions have bifurcated systems in which invalidity and infringement are heard separately and, in many cases, on timescales differing by a number of months, or even years. If a final decision on infringement is issued before validity has been heard, it is possible for the competitor to be injuncted for some time despite the patent being, eventually, found to be invalid. This is often referred to as an “injunction gap”.
For example, if ComPete is acting in Germany, you may expect to arrive at a permanent injunction in 10 to 20 months, whereas a first instance decision on validity would usually take longer, between 15 and 24 months. Of course, the injunction would likely only be effective in that one state (in this case, Germany), meaning that an infringer may be able to move their operations to minimise disruption. As such, an injunction gap may be of most use in situations where it can be employed against a difficult-to-move infringing act. For example, if the competitor is manufacturing or based in a state with a bifurcated system, and in which your patent has been validated.
Suppose now that ComPete is based in an EU, non-UPC state such as Poland.
In comparison with a company based in a UPC state, ComPete’s domicile in an EU, non-UPC state shields it somewhat from the UPC’s longarm-jurisdiction. In this circumstance, the UPC will have special jurisdiction only in relation to infringing acts in UPC states. The UPC can therefore still decide on infringement for any acts taking part in a UPC state, and its judgment will also be recognised and enforced in other UPC states in which the patent has been validated. However, its special jurisdiction does not extend to any other non-UPC or EPC state in which the patent has been validated. National actions in the relevant non-UPC state or EPC state would be needed in order to halt ComPete’s actions there.
As the above scenario demonstrates, for any situation in which enforcement is contemplated, the following facts will need to be established well before deciding on the value of a UPC action vs. actions in the national courts:
- Where is the patent validated? If there is no patent right, there can be no infringement.
- What are the infringing acts and where do they take place? Which ones are the priority?
- Where is the alleged infringer domiciled?
For an infringer domiciled in a UPC state but having manufacturing facilities in an EU, non-UPC territory, the long arm jurisdiction of the UPC may be a powerful tool that complements a central enforcement action at the UPC. Conversely, for an infringer that is both domiciled and manufactures outside of the UPC territories, a UPC action may only cover downstream acts that take place along the supply chain and at trade shows within the UPC territories. In that case, a national action where the infringer is domiciled may be enough to address the problem. For UPC territories, the UPC is already offering a compelling forum for litigants of all kinds.
Nevertheless, there may be specific circumstances where the national courts still favour the patentee. This is particularly so where the patent is old, such that little would be lost in terms of the potential to pursue future infringements by being ‘pinned out’, or where validity is a concern or bifurcation is beneficial. For such cases, national actions in, for example, Germany may be advantageous, given its significance to the MedTech market and general reputation as patentee-friendly.
Scenario 2 – Should we use the UPC for applications for preliminary injunctions?
Your European patent directed to a MedTech product has granted and been validated in UPC states including Italy and Germany. You learn that ComPete has plans to show an identical product in forthcoming trade fairs in Germany and Italy, with plans to distribute its product in other UPC states.
You want to stop ComPete from exhibiting at the trade fair with a preliminary injunction (PI). Should you do so through the national courts, or use the UPC?
The UPC has already proven itself very capable of acting quickly where applications for preliminary injunctions are concerned. In its very first month of operation, the Dusseldorf and Milan local divisions of the UPC had granted an ex parte preliminary injunction (myStromer AG v Revolt Zycling AG) and two ex parte seizures (Oerlikon Textile GmbH v Bhagat Group and Oerlikon Textile GmbH v Himson Engineering Private Limited) in circumstances involving trade shows. In September, the Brussels local division granted, within 24 hours, an ex parte inspection at the iBEDSSMA Symposium on “Multidisciplinary Treatment of Sleep-disordered Breathing” in Belgium to enable a party to gather information on a device for treating night-time breathing problems (Jozef Frans Nelissen v OrthoApnea S.L.).
More broadly, the UPC’s approach so far to provisional measures indicates a balance between speed and detail with no compromise on quality. Though the substantive matters discussed in inter partes proceedings for PIs are of course fact-specific, the courts have dealt capably with reviews of the validity of the patent (both novelty and inventive step) and consideration of claim interpretation and infringement. As you would expect, they have also considered whether there has been any unreasonable delay in seeking the provisional measures, as well as the balance of interests, which thus far have favoured the patentee. Some of these early proceedings have even included discussion over the correct criteria for the UPC in considering injunctions. This suggests a welcome desire to avoid any divergence in approach. One such inter partes PI was issued by the UPC based on amended claims (10x Genomics v NanoString) when validity of the as-granted claims was called into question by a preliminary decision of the German Federal Patent Court in a parallel action.
These early cases should give patentees confidence that the UPC can be trusted as an alternative forum for seeking preliminary injections. However, in our scenario, given that trade shows are often one-off localised events taking place in a single jurisdiction, the real question will often be whether there is any actual benefit to using the UPC over the existing national courts for PI applications.
The answer to this question lies not only with how the PI itself will be treated (as discussed above), but also with what would happen in follow-on litigation. For example, whilst Italy, Germany and the UPC have similar timeframes to reach a decision on a PI application (two to three months), the Italian courts may take two to three years for a final injunction (compared with an aim of 14 months at the UPC). As discussed above, the German system may also be slower than the UPC and also remains bifurcated.
Timing aside, and of relevance to many MedTech companies especially those based in the US, proceedings in the Italian and German courts will take place in the local languages. Conversely, as first mover with an infringement claim at the UPC, the patentee has a degree of choice when it comes to the language of proceedings, and many local division judges have indicated a strong preference to conduct proceedings in English, which in most cases will also be the language of the patent.
It is easy to see that a single application for a preliminary injunction at the UPC, covering all anticipated acts of infringement in the UPC states, offers a simpler and cheaper alternative to handling multiple applications, not least from the reduced need for local representation and translation. The patentee is also more likely to achieve consistent results at the UPC, though this could be to its detriment or advantage depending on the facts of the case and the jurisdictions in question. Nevertheless, given what we know so far about the quality of the hearings and decisions, we think holders of strong patents have little to fear from the court on PI applications.
Finally, given the speed of proceedings at the UPC, a PI could lead to a final injunction relatively quickly. As well as the factors already discussed under scenario 1, the UPC has an additional advantage when used against infringers who have not cleared the way or prepared themselves to respond with a counterclaim for invalidity. An alleged infringer is given a very short space of time in which to submit such a claim, meaning they are under considerable pressure in order to carry out the necessary searches, instruct relevant experts and prepare their invalidity arguments. The UPC rules are designed to front-load this work, which is to the patentee’s advantage in this scenario.
From what we have seen so far, the UPC looks like it will be a very useful forum for patentees to apply for preliminary injunctions, especially where acts of infringement may take place in more than one UPC jurisdiction. Patentees can expect the UPC to live up to expectations of cost-efficiency, and to reach decisions in a similar timeframe to the national courts. The UPCA rules place a significant time-pressure on infringers to file any counterclaim for invalidity. The preference of many Judges to use the English language will also be an advantage to US companies, and where the patent is in English.
Scenario 3 – What are the Freedom-to-operate implications for EPs, UPs and the UPC?
ComPete has a European patent covering their “crown jewels” medical device, sold across the EU. The patent expires in 2030, has been validated broadly in key MedTech states including at least 10 UPC states as well as non-UPC states, and has not yet been opted-out. The patent has survived an opposition and a divisional application remains pending at the EPO.
Your company, SmallCom, currently operates outside Europe. You have recently received a large investment and plan to expand your business and start selling your medical device in the states in which the patent was validated. What should you do as part of your freedom-to-operate plan?
Should I choose to start a revocation action at the Central Division of the UPC?
Given that ComPete’s patent covers their “crown jewels”, it is likely that they will assert their rights should you launch at risk in validated states. While historically, ComPete would have needed to start infringement actions against SmallCom in each specific jurisdiction, there is now a real risk that SmallCom could face fast simultaneous enforcement across all European countries via a single UPC infringement action. Therefore, a proactive central revocation action should be something to consider as part of your defensive strategy. A successful revocation action would clear the way to launch in the validated UPC states without the costs and complexities associated with multiple revocations actions before different courts. Nevertheless, timing is of the essence – forward planning is needed to ensure such an action is on file before ComPete has the chance to opt-out the granted EP, leaving individual national revocation actions the only option for clearing the way.
In spite of ComPete’s patent surviving a multi-opponent EPO opposition (and appeal), there is no presumption of validity of the patent before the UPC. For example, if the patent was upheld on inventive step by the EPO applying the problem-and-solution approach, any inventive step attacks in a central revocation action at the UPC could be bolstered with expert evidence to help convince judges that the EPO findings were not well enough informed. The reach and speed of a UPC invalidity action makes it the clear choice for clearing the way over multiple national actions (where timings to final decisions can vary considerably between states). However, if you intended to launch in any non-UPC states where the patent is validated, a parallel national revocation action would be required to invalidate the patent there.
At the very least, proactively filing a UPC revocation action highlighting the invalidity arguments, supported by expert evidence, can place pressure on ComPete and be used as a negotiation tool.
Other actions to take
Although the UPC is intended to provide a fast final decision, if launch is imminent then other precautionary defensive measures should be taken. A protective letter can be filed to reduce the risks of the UPC issuingagainst you without considering the validity of the patent in full – a well drafted protective letter should at least guarantee an inter partes hearing. To avoid the protective letter being dismissed by the UPC (as in myStromer AG v Revolt Zycling AG), the protective letter should include comprehensive arguments as to the validity of the patent and any non-infringement position, as well as why it would be disproportionate to grant a PI. While the filing of a protective letter does not guarantee that a PI will not be granted without SmallCom being given the right to argue their case, it does provide an opportunity for defendants to highlight facts which at least cast doubt on whether a PI would be appropriate, and of which the court may not otherwise be aware. The protective letter should aim to convince the Court that due process of law requires that you are heard.
Other proactive measures include the possibility of an action for a declaration of non-infringement (DNI) at the UPC if there are valid arguments as to why your medical device does not fall within the scope of the patent. The DNI, whilst ongoing, would block any national infringement actions between the same parties.
Implications of the UPC on freedom-to-operate with respect to the divisional
ComPete’s divisional presents a somewhat unknown threat, as patentees do not have to follow the same validation strategy for the parent patent and divisional. ComPete will have the opportunity to validate the divisional application even more broadly, including both UPC and non-UPC European states in which you are currently operating.
Alongside the defensive measures discussed above for the granted EP, for pending and recently granted patent applications, traditional opposition at the EPO is still a valuable tool for knocking out patents. Action must be taken within the 9-month opposition period, making monitoring the application to avoid inadvertently missing the grant date an important part of any freedom-to-operate strategy. Benefits of an EPO opposition are that in the medtech field they are typically less expensive than first instance litigation proceedings and costs are less frontloaded. Certain legal aspects also make an EPO opposition appealing to competitors. For example, where added-matter is at issue, the strict approach that is generally taken by EPO Opposition Divisions may provide the most promising route for invalidating a competitor’s patent. Additionally, if the patent is revoked following opposition proceedings, central revocation by the EPO will apply to all EPC states, not only those participating in the UPC. However, one downside to an EPO opposition is that a final decision can take some years to be reached, particularly if an appeal is filed.
The delay in reaching a final decision on an EPO opposition could be offset against filing a parallel UPC revocation action, recycling a lot, if not all, of the arguments and attacks. If the divisional application is kept under the jurisdiction of the UPC, a UPC revocation action could be initiated as soon as the patent has been granted. We have already seen a number of cases in which UPC revocation actions and EPO oppositions have been filed within weeks of one another (Hanshow Germany GmbH v SES-imagotag, Advanced Bionics AG v MED-EL Elektromedizinische Geräte GmbH, Bitzer Electronics A/S v Carrier Corporation) and, just last week, one of the claimants in the first revocation case at the UPC (Sanofi v Amgen, Inc.) added an EPO opposition of the patent to their arsenal. Since the UPC is not required to wait until the end of an opposition period to progress the revocation action, a first instance decision could be obtained within 14 months such that revocation proceedings before the UPC may be over before the patentee has even responded to the EPO opposition. These belt-and-braces approaches may be of particular interest when speed is required.