Keeping up with Belgian patent litigation: Year case law review 2022

While the AmeriKat is still recovering from
2020, her Belgian Katfriends sum-up what was
2022 in Belgian patent litigation

'Tis the season for a look at the cases that were in 2022 from around Europe and what they mean for the IP litigation themes in those jurisdictions now that the dust has settled in 2023. First up is the IPKat's Belgian friends in the form of Philippe Campolini, Gwennaëlle Kusters, Louis Bidaine, Vince Van der Wangen, Clémence Jonckheere and Anya Murphy from Belgian firm, Stibbe.

Over to our Belgian Katfriends:
 

"While the eyes of the patent community were focusing on the final preparations leading to the entry into force of the Unified Patent Court Agreement, national courts remained busy in Belgium in 2022. As in previous years (see here and here), the Stibbe IP team has prepared a selection of decisions rendered last year, to keep up with the latest developments on the Belgian patent litigation scene. These decisions namely relate to issues regarding the (absence of) liability for enforcing a PI based on a patent that later turns out to be invalid, the prima facie assessment of  validity in summary proceedings, the interplay between patent law and competition law in a telecom case, the grant of an injunction based on a patent that has not been granted yet and the reinstatement of a patent that was temporarily lost because of a translation mishap.

Enforcing a PI based on a patent that later turns out to be invalid – liable or not?

Court of appeal of Brussels, 13 October 2022, Mylan v. Novartis

Novartis owned a European patent (EP 0 948 320) relating to pharmaceutical compositions for sustained release of the HMG-CoA reductase inhibitor Fluvastatin. Fluvastatin is part of the statins family, which are used for the treatment of cholesterol. Several competitors opposed this patent before the EPO. In parallel, Novartis tried to obtain preliminary injunctions (PIs) in several jurisdictions. Novartis’ request for a PI in Belgium was rejected by the Dutch-speaking enterprise Court of Brussels. Novartis appealed this decision and ended up obtaining a PI on appeal in October 2010. At that time, the Opposition Division (OD) of the EPO, as well as the UK and Dutch Courts had already revoked the patent. Novartis kept Mylan out of the Belgian market for a year before the Technical Board of Appeal (TBA) definitively revoked its patent in September 2011.

Following this revocation, Mylan sought compensation for the damage suffered following the PI. Its claim was rejected at first instance and Mylan appealed the decision. While the case was suspended pending the decision of the CJEU in the Bayer Pharma case (see judgement here), the Brussels Court of appeal finally handed down its long expected decision on 13 October 2022.

The Court of appeal refers extensively to the Bayer judgment in its decision. According to the Court, the Bayer judgment leaves no room for applying objective liability, namely liability based solely on the fact that the patent turned out to be invalid. The Court of appeal held that a fault-based liability applies and set a strict threshold. According to the Court, the party previously subject to the PI must prove that the patentee knew or should have known, at the time of bringing and maintaining its request for a PI, or at the time of enforcing the PI, that the patent on which it relied was invalid, and that its acts or omissions were unlawful or constituted an abuse of its rights. Needless to say that such a high standard will rarely be met in practice.

The Court of appeal also rejected Mylan’s claim for compensation based on the civil law doctrine of “undue enrichment”. Under this doctrine, the victim of the damage does not need to establish a fault but must prove that a person enriched themselves at its expenses without a due cause. Although the said doctrine is expressly referred to in the Belgian legal provision governing the effect of patent revocation, the Court found that it could not order Novartis to compensate Mylan on this basis, because it would amount to a hidden no-fault liability, which was excluded by the CJEU in the Bayer case. 

Mylan appealed the judgment to the Belgian Supreme Court.

PI refused because of a prima facie lack of inventive step

President of the Dutch-speaking Enterprise Court of Brussels, 14 October 2022, Biogen v. Mylan 

Court of Appeal Brussels, 30 January 2023, Biogen v. Mylan 

Another case deserving particular attention is one between Biogen and Mylan that resulted in two rather exceptional decisions. 

Biogen developed a drug used to treat adults and children over 13 years old suffering from relapsing-remitting multiple sclerosis. The drug contains dimethyl fumarate (hereinafter "DMF") as its sole active ingredient. Biogen obtained a European patent (EP 2 137 537) relating to the use of the single active ingredient DMF, for the treatment of multiple sclerosis. The OD of the EPO declared the patent invalid due to lack of inventive step in 2016, and the TBA confirmed that decision on 20 January 2022. 

On 23 June 2022, the EPO granted Biogen a divisional patent (EP 2 653 873). The subject matter of that divisional patent related to the use of a well-defined dosage of DMF for the treatment of multiple sclerosis. 

In the meantime, the European Medicines Agency granted Mylan an EU-wide central marketing authorisation for a generic version of Biogen’s drug on 13 May 2022. Biogen appealed this decision before the General Court of the EU, but the appeal was dismissed. Biogen then decided to request a PI to prevent Mylan from infringing its divisional patent. 

This request was rejected by a judgment of the President of the Dutch-speaking Enterprise Court of Brussels of 14 October 2022. The Court found that Biogen had failed to demonstrate that its patent was prima facie valid. According to the Court, the presumption of validity of the patent was rebutted in view of the prior art filed by Mylan, since this prior art led to the conclusion that the invention lacked inventive step. The Court found that based on the said prior art, it was likely that a person skilled in the art would have arrived at the dosage described in the contested derivative patent by routine experimentation. 

The decision was appealed, but the Court of Appeal rejected the appeal on 30 January 2023. Given the presumption of validity that applies in Belgium, it is rather uncommon that a PI will be refused based on a prima facie lack of inventive step. This decision is in line with the trend in Belgian case law towards greater scrutiny of the prima facie validity of the invoked patent when it comes to granting a PI. 

A FRAND dispute without a SEP?

President of the French-speaking Enterprise Court of Brussels, 26 July 2022, Tunstall v. Télé-Secours and Victrix Socsan

Court of Appeal Brussels, 8 June 2023, Tunstall v. Télé-Secours and Victrix Socsan

The UK-based Tunstall group active in the telecare sector owns EP 2 160 038. The patent, which is not standard essential, relates to a method of encoding dual-tone multi-frequency (DTMF) digital elements into sequential tone multi-frequency (STMF) signals. The STMF technology provides increased reliability for analog devices communication on certain networks. Two proprietary communication protocols of Tunstall implement this STMF technology. Tunstall had already granted licenses on the STMF technology to hardware and software providers active in Belgium.

In 2021, Tunstall accused a client (Télé-Secours) and a competing software provider (Victrix) of infringing its patent. Unhappy with Tunstall’s software, Télé-Secours had indeed decided to order Victrix’ software. However, Télé-Secours had thousands of telecare units in operation using the STMF technology and Victrix therefore wanted a licence to ensure a reliable connexion between said devices and its own software. Victrix requested such a license from Tunstall, but was denied it. Victrix and Télé-Secours argued that this refusal was an abuse of dominant position and an abuse of economic dependence. While the patent is not standard essential, they argued that the STMF technology was necessary in order to use the existing analog hardware base because of its increased reliability over other available technologies. 

The President of the French-speaking Enterprise Court of Brussels rejected the allegation of abuse of dominant position but concluded that the refusal constituted an abuse of economic dependence against both Télé-Secours and Victrix. The prohibition of abuse of economic dependence is not provided for under EU law, but was introduced in several member states including Belgium. The Court ordered Tunstall to grant Victrix and Télé-Secours a non-exclusive licence to use the STMF protocols in Belgium for the term of the patent. The price of the license was set as the average price paid by other licensees taking into account the remaining duration of the patent. 

The judgment was recently reversed by the Brussels Court of appeal, but a further appeal before the Supreme Court remains possible. The case has not gone unnoticed in the patent and competition law communities. To our knowledge, the first instance judgment was the first Belgian judgment on the merits to rule a FRAND-like dispute. 

Future patent – present right? 

President of the Dutch speaking Enterprise Court in Brussels, 10 May 2022, Novartis v. Mylan

Another interesting decision for this year’s annual review was rendered by the President of the Dutch-speaking Enterprise Court of Brussels in summary proceedings that tackled the question of whether the holder of a patent that is about to be granted can obtain a PI prior to the said grant. 

The case concerned a drug for the treatment of relapsing remitting multiple sclerosis (RRMS) which contained the active ingredient fingolimod. Novartis received marketing authorisation for the drug in 2011, and the data exclusivity expired in March 2022. This meant that generic versions could be marketed from that day onwards. After Mylan received a marketing authorisation for its generic product, Novartis started summary proceedings to prevent the launch of the said product based on its European patent application EP 2 959 894. 

The grant of that patent had initially been rejected by the examination division of the EPO for lack of novelty. Its decision was overturned on appeal on 8 February 2022 and the case was remitted to the examination division with the explicit instruction to grant the patent. 

Following that decision, Novartis requested that Mylan confirm that it would not launch its generic product in Belgium in the period before the imminent grant of its patent. Mylan did not give such confirmation and Novartis initiated preliminary proceedings.

Novartis’ claim was twofold. Firstly, Novartis sought a PI effective as soon as the patent was granted. This claim was found inadmissible by the Court as it constitutes an actio ad futurum, and is thus expressly prohibited by Belgian law. 

Secondly, Novartis sought a PI based on unfair competition law and the doctrine of abuse of right. This time, the claim was found admissible and well-founded.

The Court first held that the urgency of the case was demonstrated by the fact that the launch of the generic product would trigger the reference price refund system, resulting in an irreparable halving of the price of the originator product and thus a permanent reduction in Novartis' revenues. In addition, the Court held that the TBA's decision ordering the grant of the patent constituted a sufficient appearance of right to justify the grant of an injunction. The Court reasoned that after the grant of the patent, the marketing of Mylan’s product would constitute a prima facie infringement of Novartis’ exclusive rights under its patent. In its reasoning, the Court weighed the parties’ interests and found that, given the limited time Mylan could market its generic product, the launch of the product would constitute an unfair market practice and cause disproportionate damage to Novartis. In light of the foregoing, the Court granted a PI for a maximum period of 6 months, considering that the patent should be granted by that time.

Lost in translation

French-speaking Enterprise Court of Brussels, 7 March 2022, Merck Patent v. Belgian State

In early 2022, the Belgian State was in the limelight in a case brought against it by Merck Patent GmbH (Merck) concerning patent translations (or rather, the lack thereof).

Owner of a European patent, Merck sought at the end of 2014 to have its patent validated in Belgium at the Belgian Intellectual Property Office (BIPO). To this end, Belgian law provided at the time that when the EP had not been granted in one of the national languages of Belgium (i.e. Dutch, French or German), as was the case in this instance (the patent had been granted in English), the applicant had to provide the BIPO with a translation into one of these languages within three months from the publication date of the mention of the patent grant. Non-compliance with this obligation was sanctioned by the retroactive loss of the Belgian part of the EP. Although Merck had specifically contracted a Belgian patent attorney to validate the patent in Belgium, the translation of the patent was not filed within the three-month deadline.

Merck, unaware that the Belgian State had consequently recorded the patent as lapsed in its register, proceeded to the payment of the annual fees of said patent. These payments were accepted by the BIPO without reservation. It was only following the payment of the third annual maintenance fee, nearly two years after the first, that Merck was finally informed by the BIPO that its patent had been listed as “without effect” due to its failure to provide a national language translation of the patent within the legal deadline. 

The Belgian State had not only failed to notify Merck of its failure to procure the translation within the three-month deadline and of the subsequent lapse of its patent, but it also took over two years for the BIPO to reimburse Merck for the undue payments. As a result, Merck had been deprived of its opportunity to request the restoration of the lapsed patent within the twelve-month period following its failure to meet the deadline for filing the translation. 

The French-speaking Enterprise Court of Brussels therefore found the Belgian State to have violated the principles of legitimate expectations and good administration. While the obligation to provide a national language translation was in itself held to be valid, the Court ruled that the Belgian State’s actions constituted faults implicating its extra-contractual liability. It reasoned that in the absence of said faults, Merck would have been informed that its EP had not been correctly validated in Belgium and would have been able to benefit from the restoration procedure provided for in Belgian law. The Court consequently ruled that the Belgian State was to reinstate the patent in force and remove the “without effect” mention from the Belgian patent register, thereby placing Merck in the position it would have been in had no faults been committed."