Keeping up with Belgian patent litigation: Year case law review 2023

The BelgianKats leaning into 
some favorite pastimes (sans the beer,
chocolate, frites....just the moules
and patent law please)

With patent practitioners diligently keeping pace with the UPC’s numerous decisions over the past year, the AmeriKat's IP friends over at Stibbe has made sure that the IPKat's readers do not miss out on what’s been happening in Belgian courts. But why does annual Belgian patent review come at the end of Summer every year?  Because decisions are not automatically published in Belgium, the team does not have immediate access to all of them at the end of the year.  Some patience is needed before the decisions are published or shared by some friendly colleagues.  But patience is rewarded.  

Over to the team of Philippe Campolini, Louis Bidaine, Vince Van der Wangen, Anya Murphy and Clémence Jonckheere who reports on another interesting year of Belgian patent law:  

"Introduction

As in previous years (see here, here and here), we have prepared a selection of decisions rendered last year, to keep up with the steady-flow of latest developments on the Belgian patent litigation scene. These decisions cover issues such as the assessment of prima facie validity in summary proceedings, the influence of foreign decisions, public prior use and the typically Belgian field of descriptive seizures. As is the case every year, the pharma and biotech sectors form an important part of the landscape.

Is the wind shifting ... ?
Brussels Court of Appeal, 30 January 2023, Biogen v. Mylan

In this typical preliminary injunction (PI) case, the Brussels Court of Appeal seems to have refined its case-law.

The dispute arose between Biogen and Mylan. Biogen sought a PI based on the Belgian part of EP 2 653 873 against Mylan in relation to Mylan Dimethyl Fumarate 120 mg en 240 mg (the generic versions of Tecfidera). The requested PI was rejected in first instance and this decision was confirmed by the Court of Appeal. The judgment on appeal deserves attention for at least two reasons.

First, EP 873 was held prima facie invalid based on a lack of inventiveness. The assessment that led the Court to this finding is detailed and considers decisions issued abroad. The Court first recalled that there is a presumption of validity, but that this presumption may be rebutted and that the Court must examine all the facts and circumstances of the case. With regard to the foreign decisions, the Court observed that none of them were a decision on the merits and that in some cases, as opposed to others, the patent was held to be prima facie valid. On that basis, the Court considered that those decisions could not play any decisive role in the assessment. However, Mylan also relied on the fact that EP 2 137 537, the parent patent of EP 873, had been revoked for lack of inventive step by the Opposition Division of the EPO. Although that ground of invalidity was not discussed by the Board of Appeal, which confirmed the revocation of EP 537 on the basis of added matter alone, the Court noted that it appeared relevant for the assessment of the prima facie validity of EP 873 given the strong similarities between the two patents. The Court then examined the parties’ arguments in detail and declared the patent prima facie invalid for lack of inventiveness. This is notable because the Court of Appeal is generally reluctant to dive so deep into validity assessment at the PI stage, and having a patent held prima facie invalid based on a lack of inventiveness is rather unusual.

Secondly, after considering the prima facie (in)validity of the patent invoked, the Court proceeded to weighing the parties’ interests in relation to the grant of a PI. The risk of irreparable harm to the patentee is a consideration that is frequently relied on by Belgian courts to grant a PI in this type of cases. In this decision, the Court of appeal refined its case law insofar as it considered in more detail the harm a granted PI might cause to the generic company. The Court notably considered that such harm would be more difficult to quantify than the harm caused to the patentee in the absence of a PI, as it cannot be evaluated how many generic products might have been sold if the generic company had been able to enter the market. The Court of appeal also considered Mylan’s diligence in contesting the validity of EP 873 at the EPO and at national level. It would be bold to conclude that the Brussels Court of Appeal reversed its case law on this point, as the Court’s refusal to grant a PI in this case was primarily based on its finding that the patent was prima facie invalid, but it will certainly be interesting to follow the development of the case law on this point.

… Or (partly) back on track?
Brussels Court of Appeal, 13 February 2023, Merck Sharp & Dohme v. Sandoz

A couple of weeks after having refused to grant Biogen a PI in the case commented above, the Brussels Court of Appeal granted one to MSD in a case against Sandoz. The Court’s decision recalls the way urgency is assessed in Belgian pharma cases. It also contains interesting considerations on prima facie validity, on the relevance of foreign judgments, and on the balancing of interests of the parties.

MSD was the registered owner of EP 1 412 357. Two SPCs had been granted on the basis of it, namely for the drug sitagliptin (SPC’047) and for the combination drug sitagliptin and metformin (SPC’031).

With regard to urgency, the Court recalled that applying for or obtaining an MA is, in itself, not an infringement act nor a threat of infringement. The Court therefore ruled that the date on which Sandoz applied for or obtained the MA for its generic drug was not relevant for the assessment of urgency. What was considered relevant by the Court was that MSD discovered in June 2022 that Sandoz had submitted a reimbursement application for its generic drug and that on 22 June 2022, Sandoz refused to guarantee that it would not market its generic drug until the expiry of SPC’031 (8 April 2023) but only until the expiry of SPC’047 (23 September 2022). Consequently, the Court considered that the urgency arose upon receipt of this communication of 22 June 2022. Only as of that moment could MSD assume that there was a serious threat that Sandoz would launch its generic drug after 23 September 2022 (i.e. after the expiry of SPC’047) and in any case before the expiry of its SPC’031. The urgency also remained at the time of the decision because the damages for the patentee risked increasing with every day that the generic drug might be marketed. Sandoz failed to prove that MSD caused an unreasonable delay, or that it created the state of urgency itself by, for instance, not having acted sooner when it became aware of the MA.

Sandoz also contested the prima facie validity of SPC’031. Although the parties referred to multiple foreign judgments to assess this, the Court ruled, in line with its judgment of 30 January 2023 in Biogen v. Mylan, that no useful arguments could be drawn from these judgments because not only were some of them based only on a prima facie assessment, whilst others were on the merits, but they concluded in different outcomes. The Court further considered that there was no reason to attach more importance to a decision from one jurisdiction than another merely because of the alleged greater specialisation of the court involved. The Court then proceeded, yet again, to a detailed assessment of the prima facie validity of SPC’031. In this context, the Court analysed the case law of the CJEU regarding Article 3(a) and 3(c) of the SPC-Regulation, and noted that there is still uncertainty about the way these provisions need to be interpreted. The Court also underlined that several requests for preliminary rulings were (and still are) pending before the CJEU in this regard. The Court concluded that it was not appropriate to resolve these legal questions in summary proceedings and that, because of the current legal uncertainty, Sandoz failed to rebut the presumption of validity of SPC’031.

Finally, the Court proceeded to a balance of interests of the parties. The Court held that the commercialisation of the generic combination drug by Sandoz would prevent MSD from exercising its exclusive rights and would thus harm its market position. The Court considered that such harm is not merely financial and that there is no certainty that such harm could (or would) be fully compensated by the award of damages. The mere fact that MSD had already enjoyed protection under its SPC’047 until 23 September 2022 did not affect this consideration. The Court concluded that MSD’s interests prevailed. Although this approach sounds more "patentee friendly" than in the previous case, it needs to be underlined that the Court’s reasoning seems to mainly rely on the findings that SPC’031 was prima facie valid and infringed. The conclusion that can be drawn from these cases is that the balance of interests does not play a crucial role in PI cases. If the patent is found prima facie valid and infringed and the urgency requirement is fulfilled, a PI will almost automatically be granted. Conversely, if the requirements are not met, the balance of interests will generally be found to weight in favour of the defendant. Maybe the wind is not shifting after all.

Do it right, do it once
Liège Court of Appeal, 27 June 2023, Proximus v. Assia EAL

The Spanish company Assia EAL learnt the hard way the importance of bringing forward all indications of infringement from the outset in descriptive seizure proceedings.

Suspecting Proximus (Belgium's leading telecom operator) of infringing its patented communication line management process, Assia EAL filed an initial application for a saisie in December 2018. This request was rejected by the President of the Brussels Dutch-speaking Enterprise Court and this rejection was then confirmed by the Brussels Court of Appeal in January 2019, on the grounds that the documents submitted by Assia EAL were insufficient to demonstrate the existence of indications of the alleged infringement. It also ruled that the unilateral request constituted an abuse of rights, considering that Assia EAL had other procedural means at its disposal to obtain the evidence it was seeking.

As its indications of infringement were rejected as insufficient, Assia EAL had numerous reports on the operation of two Proximus telephone lines carried out by bailiffs in the course of 2019. It then decided, on the basis of the additional evidence it had gathered, to file a new saisie request in February 2020. Having initially been rejected on the grounds that it had not been established that the tests could not have been carried out at the time of the first proceedings, the seizure was subsequently granted. The Brussels Court of Appeal considered that the evidence obtained was intrinsically new.

The case made its way up to the Belgian Supreme Court, which overturned the Court of Appeal's decision, holding that evidence only constitutes new circumstances if it was not reasonably available to the applicant when the first request was examined, a condition that had not been verified by the Court of Appeal.

On appeal, the Liège Court of Appeal held that Assia EAL had not established that the equipment and databases on which the bailiffs had carried out their tests were unavailable at the time it filed its first request in December 2018. The Court also ruled that Assia EAL had not established that the tests carried out in 2019 could not have been carried out a year earlier. The Court therefore found that the new circumstances on which Assia EAL relied were reasonably accessible at the time the first application was examined and that the Brussels Court of Appeal’s decision granting the saisie was to be revoked.

Sharpening the standard of proof for public prior use

Brussels Court of Appeal, 30 May 2023, Sarine Technologies v. OGI Systems

On 30 May 2023, the Brussels Court of Appeal delivered another interesting ruling in a patent dispute between Sarine Technologies and OGI Systems. The case revolved around the validity and alleged infringement of Sarine’s Belgian patent BE 1 014 912, which covers a diamond marking system using 3D mapping technology and a laser.

OGI’s invalidity attack was mainly based on the public prior use of its own “OGI Pen Marker”, a marking device working together with a 3D cartography device. The Court first recalled that the state of the art comprises everything made available to the public by means of a written or oral description, by use, or in any other way, and that there is no hierarchy between these forms of disclosure. The Court then outlined that the party relying on public prior use needs to establish when the use occurred, what was made accessible to the public, and under which circumstances. According to the Court, proof of this can be provided by any means of evidence. With regard to the standard of proof to be applied, the Court clarified that the approach of the EPO, which requires proof “up to the hilt” in cases where all evidence in support of an alleged public prior use lies within the power and knowledge of the party invoking the public prior use, does not apply in the context of a Belgian infringement dispute. Instead, the Court applied the Belgian standard of a “reasonable degree of certainty”, as specified in article 8.5 of the Belgian Civil Code. The Court found that OGI had met this standard by proving the public prior use of its Pen Marker device on the basis of invoices, client declarations, technical drawings of certain mechanical components, a declaration from the external technical engineer who made these drawings, a declaration from the external manufacturer of the mechanical components, an undated user manual, the source code of the software, and declarations and documents relating to a seminar at which the OGI Pen Marker had been presented to the public. While the standard of proof applied by the Court is allegedly less strict than the one the EPO would have applied, the admission of public prior use in Belgian proceedings is quite rare and the evidence gathered in this case was rather extensive.

The next question submitted to the Court was whether it was obvious to replace the pen of the OGI Pen Marker by a laser. There was no dispute between the parties that the use of 3D cartography devices was well known in the diamond sector well before the priority date. These cartography devices had been used for many years to analyse rough stones and determine the best way to cut them. Once the analysis was made by the cartography device, markings were placed on the stone to indicate where to cut it. At the time, these markings were placed with a pen, not with a laser. Lasers capable of marking stones already existed and had been used to engrave indications on the girdle of cut diamonds for many years, but Sarine argued that no one had come up with the idea to combine a 3D cartography device with a laser marking device. It argued that such a change went against deep-rooted traditions and against the deeply held belief in the diamond industry that lasers should not be used for placing cutting lines on rough stones, given the risk of damaging the stones. OGI contested this and argued that the reason why the industry had not yet switched to laser marking at the priority date was not because of technical obstacles, but because of the high price of lasers and because the diamond industry is conservative and was attached to traditional ways of marking stones with a pen. The Court agreed with OGI that economic considerations have no place within the framework of the technical analysis of the state of the art and that the existence of a technical bias must be proven taking the person skilled in the art into consideration, which Sarine had not done."