Key decisions at the EPO and UPC - February edition

Part 1 – T 295/22

Relevance of the Decision and General Principles

According to Art. 54 (5) EPC European patents may be granted for further medical uses of known compounds. Since G 2/08, it is an ongoing debate in Europe what is meant by such further use and how broad such use could be defined. For example, in case of a further medical indication, it is often discussed how specific the indication needs to be defined in the claims to be qualified as such further use. With respect to a further mode of administration in the course of an otherwise known medical treatment, the Guidelines in G VI. 6.1.2 by referring to T 51/93 state in Example 2 that such further mode is merely illustrative and cannot contribute to novelty. T 295/22 now makes clear that the term “use” in Art. 54 (5) EPC needs to be interpreted broadly. This is good news for patentees in the pharmaceutical field.

The reasons/decision

Unfortunately, as is common for EPO TBA decisions these days, T 295/22 is clouded with many formal issues, mainly admissibility questions. Also in this regard, the decision is worth reading, at least for EP practitioners. In this article, however, we will focus on the material issue, namely the interpretation of the term “use” in Art. 54 (5) EPC.

Claim 1 as pending at the time point of the oral hearing in T 295/22 reads as follows (emphasis added):

A compound (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione (apremilast) or pharmaceutically acceptable polymorph, salt, solvate or hydrate thereof for use as a medicament, wherein the medicament is administered orally.

As concluded by the Board in T 295/22, only the oral administration could contribute to the patentability of the claimed subject-matter. Contrary to the statement in the Guidelines, said oral administration was found to be a technical feature of the claim according to G 2/08. This deviation was justified by the fact that T 51/93 (cited by the Guidelines) refers to a claim in the so-called Swiss type format which is not further allowable under the EPC 2000 (Reason 4.1 of T 295/22). To our understanding, this is correct in view of G 2/08 (Reasons 5.10.3), which was issued after T 51/93 and refers to the patentability of second medical use claims in the format of process restricted product claims under the EPC 2000.

However, and unfortunately for the patentee, the oral administration was found to be not inventive. The cited compound, a PDE4 inhibitor, was already known in the art, and the oral administration of PDE4 inhibitors in general was already suggested in the prior art. The Board acknowledged that the specific PDE4 inhibitor in the claim was surprisingly effective when administered orally, but considered this extra effect irrelevant in view of the knowledge of the skilled person that an oral administration was per se advantageous (Reason 4.5 of T 295/22). This finding is in agreement with the case law on the so-called “bonus effect” (see Case Law Book, I.D.10.8).

Take Home Message

It is good news for patentees that T 295/22 confirms that potentially any new use in a second medical use claim is to be considered as a technical feature and could contribute to patentability. However, it also confirms that surprising effects of such a new use can only be decisive if this use was not already per se suggested in the prior art. A potential option to overcome such an objection could be to specify the claimed mode even further in the claims and to demonstrate that the surprising effects are due to these further specifications, which are not be suggested in the art. This option was not available to the Patentee in T 295/22, also because he only filed such a claim during oral proceedings, and the Board did not admit this claim into the proceedings since it was considered to be late filed.

Part 2 – First anti-anti-suit injunction at the UPC

Relevance of the decision

On 11 December 2024, the Munich Local Division (LD) of the Unified Patent Court (UPC) granted for the first time an anti-anti-suit injunction (AASI) pursuant to Rule 206 et seq. of the Rules of Procedures (RoP). This decision is noteworthy for several aspects.

First of all, the LD - assessing its competence over the case according to Articles 32 and 33 of the Agreement on a Unified Patent Court (UPCA) - stated that the judicial initiatives put in place by the defendant, aimed at preventing the applicant from continuing or initiating legal proceedings to protect its patent rights in jurisdictions other than the one in which it applied for the anti-suit injunction (in this case in the United States), amount to an imminent patent infringement. Therefore, as we will see, the conditions of Articles 32 and 33 UPCA must be deemed to be fulfilled.

Secondly, verifying the requirements for granting an application for provisional measures (in this case of an AASI), the LD noted that the patent owner’s interest in enforcing its patent rights before the competent authorities, including the UPC, must be considered prevailing over those of the defendant, which indeed is not prevented from enforcing its rights in any whatsoever.

General Principles and Key Facts

Before addressing the case merits, we need to define ASI (anti-suit injunction).

In short, an ASI is a petition filed before the judicial body of a given State in order to obtain an order that prevents the other party from taking action or to pursue proceedings already initiated in other States to protect its rights - in this case, rights relating to standard essential patents (SEPs).

The legitimacy of these proceedings is generally subject to two orders of objections: the first is that these actions may inhibit judicial cooperation among States and, in particular, jeopardize the sovereignty of each State to set its own jurisdiction in a given dispute; the second is that said proceedings may interfere with everyone's fundamental right of access to justice.

For these reasons, these proceedings are not admitted in all jurisdictions. Indeed, on the legitimacy of this type of measure, the Court of Justice of the European Union already expressed its position in the case C-159/02, where it stated that it could not be considered to comply with the system of mutual trust between Member States, laid down in the 1968 Brussels Convention [now Regulation EU No. 1215/2012], “a prohibition imposed by a court, backed by a penalty, restraining a party from commencing or continuing proceedings before a foreign court”. The same conclusion was even more recently expressed by the same Court in the well-known 2009 ruling in case C-185/07, where it stated that “It is incompatible with Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters for a court of a Member State to make an order to restrain a person from commencing or continuing proceedings before the courts of another Member State on the ground that such proceedings would be contrary to an arbitration agreement”.

While these measures are not recognised by EU Member States, they are relatively common in other countries, such as the United States. In the US, the only available measures against anti-suit injunctions are known as anti-anti-suit injunctions, which are orders from the judicial authority to withdraw the request for an ASI made in another country.

In light of the above, we shall now examine the facts that prompted the initiation of the proceedings before the Munich LD and the arguments presented by the applicant in support of its application for ex parte provisional measure (anti-anti-suit injunction).

The case originated from an application for ex parte provisional measures under Rule 206 RoP filed by the company incorporated under Chinese law Huawei against the US company Netgear Inc. and two other companies of the same group.

In a nutshell, the applicant Huawei argued the following before the LD:

• Huawei is the owner, among others, of European patents nos. 361189 and 3678321, which are essential for the Wi-Fi 6 standard;
• despite numerous invitations to negotiate a licence agreement, Netgear had not entered into any agreement and thus unlawfully offered and advertised products (such as, for example, routers and modems) for the use of Wi-Fi 6;
• in view of said conduct, the applicant had been forced to initiate numerous infringement proceedings both before the UPC (UPC_CFI_9/2023; UPC_CFI_168/2024), the Munich Regional Court and in China. With regard to the infringement proceedings pending in China, in particular, the applicant noted that the Jinan Intermediate People’s Court had already issued a first instance judgment, against which an appeal was lodged, ascertaining the infringement by Netgear of two of its Wi-Fi 6 patents;
• the defendant, from its part, initiated proceedings before the US District Court of California to establish Huawei’s alleged unfair competition conduct to its detriment and obtain an ASI that would prevent Huawei from enforcing its patent rights - both in pending proceedings as well as in actions to be initiated - not only before the UPC but also in other jurisdictions; and
• due to the serious damages possibly resulting from the granting of the requested ASI, of which it had become aware on 4 December 2024, the following 9 December the applicant decided to file an application for provisional measures seeking an order preventing the opposing parties (i) from further pursuing the action initiated in the United States to obtain an anti-suit injunction; and (ii) from initiating analogous actions.

The application’s grounds were briefly the following: i) the application for an ASI is to be considered unlawful under the applicable German and EU law, as it interferes not only with Germany’s and UPC’s judicial sovereignty, but also with the applicant’s right to enforce its industrial property rights; ii) in the event the UPC fails to adopt provisional measures before the adoption of ASI, the applicant would suffer considerable damages, as it would be prevented from enforcing its patent rights and would be obliged to withdraw actions already pending, under threat of heavy penalties. Moreover, the applicant insisted in particular on the fact that the application for provisional measures had to be necessarily granted ex parte pursuant to Rule 206, paragraph 3, RoP, and therefore in the absence of a prior hearing of the other party, considering that it was possible that the US Court would adopt an ASI within a short time frame.

The reasoning of the Munich Local Division

After summarizing the events and arguments for the ex parte provisional measures application, we now address the grounds for the Munich Local Division's final ruling.

Firstly, the LD clarified the existence of the UPC's competence to hear the dispute, and more specifically its territorial competence, under Articles 32 and 33 UPCA respectively. Indeed, as far as the UPC's competence is concerned, the conditions laid down in paragraph 1 letters a and c, according to which the Court has exclusive competence in respect of “actions for actual or threatened infringements of patents” and “actions for provisional and protective measures and injunctions”, are met. This because, according to the LD, patent infringement can be envisaged not only when the patent is subject to an unlawful use, but also when it is prevented from being enforced. The latter scenario being necessarily realised in the present case, where the defendant took an action in the United States to prevent the applicant from obtaining or enforcing a decision of the UPC. Moreover, as for the competence of the Munich LD, the condition referred to in Article 33, par. 1 lett. a UPCA was considered fulfilled.

Then the LD assessed the requirements for granting provisional measures under Article 62 UPCA and Rule 206 RoP. These include: 1) proving with certainty that a patent infringement occurred or is imminent; 2) balancing the parties' interests, considering the potential harm of granting or refusing the application; and 3) the urgency of the measure.

With regard to the first requirement, it was considered that the imminent infringement of the applicant’s patent rights by the defendant had been proven, as the latter, through its action in the United States, sought to prevent the former from enforcing its patent rights within the territory of the European Union and also before the UPC. Moreover, considering that intellectual property rights equate property rights, such initiative inevitably resulted also in a violation of paragraphs 1 and 2 of Article 47 of the EU Charter, according to which “Everyone whose rights and freedoms guaranteed by the law of the Union are violated has the right to an effective remedy before a tribunal in compliance with the conditions laid down in this Article. Everyone is entitled to a fair and public hearing within a reasonable time by an independent and impartial tribunal previously established by law. Everyone shall have the possibility of being advised, defended and represented”.

As for the second requirement, in its discretionary exercise of the balancing of interests, the LD noted that if an ASI were to be issued in the United States, the applicant, in order to avoid being subject to the substantial penalties accompanying each violation, would have been not only unable to proceed before the UPC but forced to withdraw actions already pending before it. This would result in significant damage to its patent rights, which would suffer considerable commercial devaluation.

These circumstances were deemed particularly significant by the LD, which concluded that the potential damages deriving from the dismissal of the application were greater than those potentially suffered by the defendant further to the granting, the latter consisting only in the obligation to withdraw the action initiated in the US to obtain an ASI.

As for the third requirement (urgency), the latter was held to be met, since it can only be considered absent if it is proven that the applicant was negligent in protecting its rights. The LD noted that the applicant, having become aware of the opposing party's action in the United States on 4 December 2024, immediately reacted filing the application for provisional measures the following 9 December 2024. This conclusion did not change even considering the date of 20 November when the applicant learned of the defendant’s possibility of bringing such action. Additionally, the LD noted that the application was also objectively urgent, as the ASI could have been issued at any moment by the US Court, making it impossible to wait for a decision on the merits.

Furthermore, the LD deemed that the conditions for granting provisional measures ex parte were met, as the applicant duly demonstrated that it would have suffered an irreparable harm from the delay needed to hear the counterparties. In this case, the irreparable harm could have arose from the possibility that the defendants, once informed of the application, could request an acceleration of proceedings in the United States.

Precisely in consideration of all the reasons outlined above, the LD ultimately granted the application and thus prohibited the defendants from prosecuting proceedings for an anti-enforcement injunction or anti-suit injunction before the US District Court of the Central District of California or from seeking other equivalent judicial or administrative measures.

For completeness, it is noted that, following the decision under discussion here, the parties withdrew proceedings pending before the UPC and, in proceedings pending in the United States, filed a joint motion on 3 January 2025 to obtain a stay of proceedings in order to reach a settlement agreement. This is because, as emerges from the Sisvel’s website, Netgear has taken a Wi-Fi 6 pool licence from Sisvel.

Take Home Message

From this order of the Munich LD it can be inferred that the UPC, in accordance with European law on this point, recognises anti-suit injunctions or anti-enforcement injunctions as unlawful insofar as they interfere with the power of the same UPC to decide on its competence to hear the dispute and, even more, insofar as they interfere with the right of the patent holder to access justice. Moreover, such actions falling within the expression of “threatened infringements of patents”, are such as to ground the exclusive competence of the UPC to hear the dispute.