In its judgment dated 7 December 2017 (case C-329/16), the Court of Justice of the European Union (CJEU) considered that software, of which at least one of the functions makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device within the meaning of the Directive 93/42/EEC concerning medical devices (MDD).
In Le Soir of 27 July 2017, Philippe Campolini and Gaëtan Goossens comment on the implications of Data Protection Law and the upcoming GDPR when the manufacturers of electronic home appliances intend to sell the data collected through these devices to companies like Amazon, Google or Apple, to enable them to personalize shopping offers.
A few years ago, many were shocked by the news that thousands of women across the world suffered harm caused by wrongly manufactured breast implants. For several years a French manufacturer had used industrial silicone instead of medical grade silicone to produce breast implants, in violation of the approval that had been issued by the notified body. Furthermore, a BBC investigation revealed that hundreds of thousands of individuals across the world could have been exposed to dangerously high levels of toxic metals from failing hip implants.
These revelations were some of the reasons why the European Commission issued, on 26 September 2012, two new regulation proposals to replace the three existing medical devices directives. One of the proposed regulations concerned in vitro diagnostic medical devices only, while the other one related to all other sorts of medical devices. These proposals marked the beginning of a long legislative process that led to the renewal of the regulatory framework on medical devices.
On 5 April 2017, the regulation on medical devices (hereinafter “MDR”) and the regulation on in vitro diagnostic medical devices (hereinafter “IVDR”) were adopted. They were published on 5 May 2017 and entered into force on 25 May 2017. The MDR will apply from 26 May 2020 and the IVDR from 26 May 2022.
Curing rules on parallel import of pharmaceuticals?
CJEU and Belgian Supreme Court on the interaction between free movement of goods and trademark rights
On November 7, 2016 the Belgian Supreme Court (Cour de cassation – Hof van cassatie) gave judgment in two cases regarding the repackaging of pharmaceuticals, wherein it ruled in favour of the parallel importer with respect to the exhaustion of trademark rights principle. Simont Braun represented with success the defendant in these two cases.
Just three days later, on November 10, 2016, the CJEU gave a preliminary ruling on a question submitted by a Danish court in a similar case.
All three cases dealt with the issue whether a trademark owner can oppose the parallel import of trademarked pharmaceuticals of which the packaging format has been modified.
The Belgian proceedings concerned the medicine ‘Cozaar’, containing the active component ‘Losartan’ in a dose of 50 milligram in one case and a dose of 100 milligram in the other case, both manufactured by Merck and imported by Pi Pharma into Belgium from Poland. In both proceedings Pi Pharma bought the most common Polish packaging format of 28 tablets and repackaged these in formats of 98 tablets for the Belgian market.
EUROPEAN PATENTS IN BELGIUM – Late filing of a translation –
New special restoration procedure with retroactive effect –
Deadline: 05 January 2017
In a previous news, we commented on the special restoration procedure that was instituted by the Belgian legislator in favour of European patent holders that had forfeited their rights because the translation of their patent was filed too late with the Belgian IP Office (OPRI). Amongst other things, we noted in our previous news that this special restoration procedure, only available for a one-off period of six months ending on 22 March 2015, was only open (under certain conditions) to European patents that had been subject to an opposition or a central limitation procedure. We commented on that limitation by saying that this requirement “might be viewed as a form of discrimination that the Constitutional Court could judge contrary to the equality rule, combined with the respect due to the right of property.” We concluded as follows:
“Although the law only refers to European patents “maintained as modified or limited”, we believe that it should also be possible to file a special restoration application for patents issued without opposition or limitation. If the OPRI were to refuse to grant restoration and that decision were appealed against, it can doubtlessly be expected that a reference would be made to the Constitutional Court for a preliminary ruling.”
Our analysis was confirmed by a judgment of March 2015 by the Brussels Court of Appeal. As a consequence, and to avoid any further problems, the Belgian legislator recently instituted a new special restoration procedure. This time the procedure is also open to European patents that were not subject to opposition or limitation procedures and that could therefore not benefit from the initial special restoration procedure.
What are the requirements for being able to use this new special restoration procedure?
- The date of grant of the European patent cannot be later than 21 September 2014;
- The patent owner had no access to any of the other restoration procedures instituted by the Belgian legislator (i.e. the “normal” restoration procedure in case of translations filed with delay or the first special restoration procedure ending on 22 march 2015) ;
- A translation of the patent has been filed, but too late;
- The request for this new special restoration is filed before 5 January 2017.
If you think one of your European patents, or one of your client’s European patents, could be in this situation, you should urgently consider to file a request for restoration with the Belgian IP Office. We are at your disposal should you need any further information on the above.
Fernand de Visscher Eric De Gryse Philippe Campolini
From the 1st of January 2017 onwards, the filing of a translation with the Belgian Intellectual Property Office will not be required any longer in Belgium for European patents delivered in English.
Please note: the new regime will only be applicable to European patents of which the mention of the grant or the maintenance, in amended or limited form, are published from the 1st of January 2017 onwards.
If the mention is published before that date, the filing of a translation of the European patent will still be required.
See here the letter of the Belgian Intellectual Property Office of 30th of September 2016.
F. de Visscher, E. De Gryse and Ph. Campolini
In Belgium, as well as in France, many strived for years in order to introduce a new copyright exception, which would allow the reproduction and communication to the public of works which are permanently situated in public places (the so-called « panorama exception »). Next to France, Luxemburg, Italy and Greece, Belgium was one of the few EU Member States, which did not foresee such an exception in its copyright laws.
In Germany the concept «Panoramafreiheit» exists already since 1876. And there is a similar exception in the United Kingdom, introduced by the de Copyright, Designs and Patents Act of 1988, which even applies to the interior of public buildings. Eventually Directive 2001/29 on the harmonisation of certain aspects of copyright and related rights in the information society foresaw in 2001 the possibility to create exceptions to the property rights when there is «use of works, such as works of architecture or sculpture, made to be located permanently in public places» (article 5.3, h of the Directive).
After much debate, the French Assemblée Nationale decided on 21 January 2016, to line up with the numerous Member States which already knew the exception by accepting a freedom of panorama, however, limited to usage with non-lucrative ends.
As is clear, the exception has a vast number of varieties. The one, which was ultimately introduced in Belgian by the law of 5 July 2016 allows “the reproduction and communication to the public of works of visual, graphic and architectural art, which are made to permanently remain in public places, provided that the work is reproduced as it is and provided that such reproduction does not conflict with a normal exploitation of the work and does not unreasonably prejudice the legitimate interests of the author”. The preparatory works point out that the concept «public places» is not applicable to the interior buildings, which are not permanently open to the public. Furthermore, the text points out that the work must be reproduced «as it is», which means that «in the public space». These clarifications seems to prevent certain acts from being possible, as for example photomontages containing the photographed building.
During the legislative process, the question arose whether the French model of the exception should be taken as a reference, and if a direct or indirect commercial purpose should be excluded from the exception. One may think, for instance, at the selling of postcards containing a picture of the copyrighted work. An amendment in that sense was proposed, but was ultimately rejected. The reason given to that rejection was that this limitation was unnecessary: the guarantee that the reproduction does not conflict with a normal exploitation of the work and does not unreasonably prejudice the legitimate interests of the author, would be sufficient to prohibit such commercial uses. These conditions correspond to the second and third conditions of the so-called triple test (see article 5.5 of the Directive).
What are the practical consequences for Belgian law and what exactly will change? Inspired by the expression of Rémi Mathis in an article in the newspaper Le Monde (http://www.lemonde.fr/idees/article/2011/09/27/rendre-aux-francais-leur-paysage-architectural_1578046_3232.html) we can hold that it will « give Belgians their architectural landscape back ».
Some will be surprised to read that before the introduction of the panorama exception, it was prohibited to reproduce or communicate to the public a picture of which the central subject was a copyright protected work present in the public place. Therefore, it was necessary, for example, to ask the authorisation of the architect of the Atomium (or his successors in title) to publish a picture of it on the internet.
However, such reproduction or communication to the public was not prohibited in all situations. When the copy was purely made for private purposes, it was allowed. Tourists could, thus, freely take pictures of the Atomium, as long as these were not afterwards published. Moreover, Belgian law already contained an exception to the reproduction and communication to the public of a work located a public place, provided that the main subject of the reproduction or communication was not the work itself. Therefore, a picture of a couple posing in front of the Atomium, for example, could legally be put on the internet.
Because of the introduction of the panorama exception, it is nowadays possible to photograph all visual, graphic and architectural works, which are intended to be permanently placed in public, even if the general subject of the photo is the protected work itself, and furthermore, to communicate these pictures without authorisation of the author of the work concerned. However, attention has to be paid to the limitations of the new exception. Indeed, the work has to be reproduced of communicated to the public as it is placed in the public space. Furthermore, the reproduction or communication may not conflict with the normal exploitation of the work and may not unreasonably prejudice the legitimate interests of the author.
Jochen Baes Philippe Campolini Fernand de Visscher
PDF document : NEWS_en.pdf
In the court decision of 7 July 2016 (C-567/14, Genentech) the Court of Justice of the European Union reaffirmed the solution as presented by the Court in its decision of 12 May 1989 (C-567/14, Ottung): the prohibition on anti-competitive agreements (article 101, §1 TFEU) does not affect the contractual obligation of a fee for the use of a technology that is not or is no longer covered by a patent, on the condition that the licensee is at every moment in the possibility to end the existing agreement.
The Court had already stated that such a clause could be the reflection of the value parties give from a commercial point of view to the exploitation possibilities the license agreement is about.
In the most recent case, the question was treated from a small different point of view, but the solution firmly stayed the same. The Court underlined the importance of the fact that a licensee is free to end the agreement at all time.
The license concerned (1992) covered a worldwide non-exclusive license regarding certain technology, which was protected by a European and two American patents. The European patent was declared null and void several years after by the OEB (1999), while the American patents, although likewise attacked, remained in place.
Next, the licensee ended the agreement, while the American patents were sill applicable.
In this case, the Court regarded the two American patents, which protected the technology concerned as the only relevant patents: the patents were not declared null and void, but the Court held that the licensor did not use the patents after the termination of the agreement (counterfeit).
The dispute arose because the licensee failed to pay the royalties as was foreseen by the license agreement. When considering the dispute before him, the arbitrator accepted the responsibility of the licensee to pay the royalties. The punishment he had foreseen was the subject of an action for annulment with the Court of Appeal in Paris, which was asked to render a judgment regarding the compatibility of the solution rendered by the arbitrator with article 101, §1 TFEU (prohibition on anti-competitive agreements).
The arbitrator had reached its solution taking into account the German law regarding license agreements. He was of the opinion that the commercial purpose of the parties was to lighten the risk on the licensee to face infringement proceedings of the licensor, while using the technology. This view was opposed to the opinion of the licensee, who argued that with the absence of an infringement, no compensation needed to be paid.
Thus, the relevant question comprised of knowing if article 101, §1 TFEU precludes that an obligation within such an agreement is put on the licensee to pay a compensation fee for use of the technology, in the period when a license is applicable, while a annulment of the patent is still a possibility or, like in the case at hand, a declaration non-infringement of the patents, which protect this technology, by other parties.
The Court of Justice pointed out that the solution put forward in the decision of 12 May 1989 is a fortiori applicable in this case. While a license agreement is in force, the payment is due, even after the patent expires. Thus, this also applies when the patent is still in force (which was in casu the situation, the American patents stayed applicable until termination of the license agreement by the licensee and where not declared null and void).
In our opinion two main elements played a role when the Court considered the case, being on the one hand, the fact that in German law regarding license agreements, a non-infringement has no influence on the payment of the royalties. The reason is that the commercial purpose of the parties consists in protecting the licensee for the risk for infringement. On the other hand, another element is the fact that the licensee has the possibility, as was in the previous case, to terminate the agreement at every moment.
The payment of royalties regarding a patent, while it has become inapplicable or declared null and void, or when there is no infringement, primarily is debated in the framework of anti-competitive restrictions. As the reasoning of the case clearly indicates, the particularities of every separate case will have to be considered.
Fernand de Visscher
PDF document The_payment_of_the_royalties-_EN.pdf:
L. de Brouwer "Le droit des jeux plublicitaires", Larcier, 2016.
Parmi les méthodes de promotion des ventes, les jeux publicitaires occupent une place singulière : les loteries, tombolas, jeux et concours publicitaires n’offrent en effet au consommateur que l’espoir d’un gain, mais chargé, il est vrai, d’un pouvoir attractif souvent convaincant.
Les nombreuses règles légales qui les gouvernent se situent à la croisée de deux secteurs d’activités réglementés de manière presque antinomique : d’un côté, les loteries et les jeux de hasard sur lesquels l’État exerce un monopole et un contrôle souverain ; de l’autre, le commerce où règnent les principes de liberté et de libre concurrence, mais encadrés par les dispositions protectrices des consommateurs.
La mise en œuvre d’un jeu publicitaire oblige son organisateur à se poser des questions essentielles avant de porter son choix sur l’une ou l’autre formule : concours ou loterie ? jeu ou jeu de hasard ? opération à lancer sur des supports classiques, on air ou on line, via un site internet ou des réseaux sociaux ? lots en espèces ou en nature ? intervention d’un huissier de justice ? risque de disqualification ? Quant à la rédaction du règlement,
il soulève d’autres questions : les clauses sont-elles toujours licites, pertinentes et opposables à chacun des participants ?
Le lecteur trouvera dans le présent ouvrage des réponses aux multiples questions que posent le choix, la mise en œuvre et la gestion des jeux publicitaires. L’ensemble des règles qui leur sont applicables sont exposées d’une manière ordonnée et synthétique, ce qui n’exclut ni l’approfondissement ni la critique. Les nombreux exemples pratiques, tous tirés de la jurisprudence, illustrent le commentaire. À dessein, l’auteur utilise un langage clair et accessible à tous ceux auxquels l’ouvrage s’adresse : les professionnels de la communication et du marketing, les juristes et les joueurs.