Future of the UPC system increasingly uncertain
It seems that 2019 will be another bumpy ride for the goal of setting up the Unified Patent Court and system of unitary patents, despite much hope and effort. The UPC will only come into force after Germany ratifies the United Patent Court Agreement (for more information on the ratification process, click here). This process is moving slowly due to complaints about the UPC’s compatibility with the German Constitution. This case was filed before the German Constitutional Court in March 2017 and is still pending.
In addition, the uncertainty around a possible Brexit, in whatever form, might also impact UPC’s launch or even its existence. For more information on Brexit and IP rights, see our earlier Brexit: Deal or No Deal newsletter.
Export manufacturing waiver to be introduced
In 2018, the European Commission proposed to amend the current EU regulation on supplementary protection certificates (SPCs). The amendment will introduce an “export manufacturing waiver”. SPCs are unique IP rights intended to compensate pharmaceutical companies for losing their effective patent term resulting from a delay in getting regulatory approval for their products. The proposed waiver would allow EU-based manufacturers to produce a generic or biosimilar version of an SPC-protected pharmaceutical product if the product’s sole destination is to a non-EU market where protection has expired or never existed. The Commission’s Committee on Legal Affairs is scheduled to vote on amendments to the proposal in January 2019. As a next step, the European Parliament, Commission and Council may reach consensus over the amended regulation in spring 2019.
Trademark reform entering final stage
The Trade Mark Harmonisation Directive continues to affect national trademark legislation in the EU. While several important changes have already been implemented in the Benelux region, there are more to come in early 2019. An important change is the introduction of a new fee structure as of 1 January 2019. In addition, the requirement that signs should be graphically represented in order to be registered will be abolished as of 15 January 2019. This means that it will be possible to register signs such as sounds. A third important change is the introduction of certification marks. These are marks relating to the guarantee of specific characteristics of certain goods and services.
EU copyright rules to be made fit for the digital age
The EU will continue to modernise EU copyright rules to make them fit for the digital age, ensuring that all authors can rely on the proper protection of their works. The European Commission has already proposed a draft regulation and a draft directive on copyright in the digital single market. The proposals increase access to content across the EU by simplifying copyright clearance, and they create a fairer marketplace for online content by implementing new transparency obligations and a negotiation system. The proposed directive has been heavily criticised due to its controversial provisions on the digital use of press publications, and obligations for online content-sharing service providers. In July 2018, the European Parliament voted to reopen the directive proposal for debate and in September 2018, it became clear that the proposal would be further discussed between the Commission, Council and Parliament. They are expected to come to a conclusion in early 2019.
New EU customs plan to be launched
Following up on the previous 2013-2017 Action Plan, the EU council adopted a new EU customs action plan in autumn 2018. The action plan’s objective is to combat intellectual property rights infringement over the years 2018 to 2022. The Council has invited the EU Commission, in cooperation with the member states, to produce a further detailed roadmap with specific action points by spring 2019.
Developments in the Netherlands
Following the example of many other countries, the Netherlands will see the “pharmacy exception” come into force – as part of an amendment to the Dutch Patent Act – in early 2019. This means that pharmacies will be allowed to prepare medicinal products, and this will lead to a reduction in costs for patients.
In addition, two Dutch bills relating to gambling which we flagged last year (and the year before), are still pending. The first bill relates to the demerger and sale of Holland Casino, and the second bill introduces a licensing regime for online gambling. In addition, there is some potential media-related legislation in the pipeline. A bill relating to the modernisation of the Dutch Media Act 2008 remains pending. Another bill relating to an integral policy for allowing commercial radio activity is likely to come into force in 2019.
It remains to be seen which of these proposals will actually make it into law in 2019.
Other exciting news for the Netherlands is the intended relocation of one of the American Food Drug Administration’s (FDA) foreign offices from London to Amsterdam, following the move from London to Amsterdam of the European Medicines Agency (EMA).
Guidance from Luxembourg
Finally, we expect some interesting rulings from the ECJ in 2019. Looking at the IP cases in which the Advocate General has already delivered an opinion, we might expect some important clarification on:
- SPCs for medicinal products and the requirement to obtain market authorisation for a medicinal product (Abraxis BioScience)
- Carve-out that manufacturers of generic medicinal products introduce for their products in order to stay away from patented indications (CtBG/Warner-Lambert)
- Whether unlicensed sampling constitutes copyright infringement (Pelham and others)
- Trademark registration of a certain colour mark that is depicted in the application as a figurative mark (Hartwall), and
- The consequences of a trademark’s descriptive nature for proof of genuine use (Pandalis/EUIPO).