On 26 March 2019, a fierce battle took place in the arena of the EU Parliament. Arguments flowing back and forward resulted in a close majority in favour of the supporters of the new Directive (EU) 2019 of the European Parliament and of the Council on copyright and related rights in the Digital Single Market and amending Directives 96/9/EC and 2001/29/EC (hereinafter: the New Copyright Directive). You may find the debate here and the final text as adopted here.
The FPS Economy has just appointed, for their legal expertise, Fernand de Visscher as President and Emmanuel Cornu as a member of the Industrial Property section of the Council for Intellectual Property.
At last, after roughly two years, the EU Directive 2016/943 (hereinafter: The Directive) of 8 July 2016 has finally been transposed by the long-awaited Belgian Law of 30 July 2018 on the Protection of Trade Secrets (hereinafter: The Law) that entered into force on 24 August 2018.
The Law brings clarity, among other things, by giving a legal definition of “trade secrets” and provides useful mechanisms that allow more effective enforcement of the right to the protection of trade secrets.
Considering that The Law is in large part a copy/paste-exercise from The Directive, we first recollect the main objectives and principles of The Directive.
On 1 June 2018, the amendments to the Benelux Convention on Intellectual Property (BCIP), adopted in 2014, entered into force. From 1 June on, new powers are attributed to both the Benelux Court of Justice (BCJ) (1) and the Benelux Office of Intellectual Property (BOIP) (2). Furthermore, a new opposition ground – currently already available to opponents of EU trademarks – is available (3). The implementation of the second EU harmonisation directive is on track but still not in force.
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