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Pharmacy compounding of patented medicines in the Netherlands

The pharmacy exemption came into force on 1 February 2019

In many other European countries (such as Germany, France and the UK), pharmacists were already allowed to prepare a patented medicine on a small scale for their own patients under a pharmacy exemption. This was not the case in the Netherlands, at least, not until 1 February 2019.

Article 53(1) of the Dutch Patent Act 1995 (“DPA“) provides a list of exclusive acts reserved for the patent holder. On 1 February 2019, Article 53, third paragraph, second sentence, of the DPA came into force and introduced a pharmacy exemption in Dutch patent law. Article 53, third paragraph, second sentence of the DPA reads as follows (unofficial translation):

“3. […] The exclusive right shall neither extend to the preparation for direct use for individual cases on medical prescription of medicines in pharmacies, nor to acts concerning the medicines thus prepared.”

The pharmacy exception is meant for the preparation of pharmaceuticals, by pharmacists, for direct use, on prescription, in individual cases. In a letter to the House of Representatives, the responsible ministers have clarified that this exception does not aim to allow preparation of a patented medicinal product on a structural scale without the consent of the patent holder, as this would undermine his right.

The entry into force of the pharmacy exemption in the DPA reflects a broader trend in the Netherlands of government favoring pharmacy compounding, also as a potential alternative to expensive medicinal products.

At the end of 2018, the Dutch Health and Youth Care Inspectorate (“IGJ“) published a report about the pharmacy compounding of a specific medicinal product by a Dutch hospital pharmacist.  The report’s general conclusion is that pharmacy compounding by pharmacists for their own patients is allowed, even if (more expensive) registered alternatives are available. IGJ did note that pharmacists should make sure that the compounded medicinal product meets the safety and quality requirements, and should take into consideration that advertising of pharmacy compounded medicinal products is not permitted.

This article is published by the Amsterdam Life Sciences team. For further information or additional input please contact Bert Oosting, Hein van den Bos or Joost Duijm.

Stuttgart Court of Appeals: Unfair conduct when textile components are indicated in English in Germany

At the end of 2018, the Stuttgart Court of Appeals [Oberlandesgericht] clarified that, pursuant to Regulation (EU) No. 1007/2011 on textile fibre names and related labelling and marking of the fibre composition of textile products (hereinafter: the Textile Regulation), in Germany the components of a textile product must be indicated in German. The use of English terms not taken on in the German language (in this case “SHELL” for the outer layer and “INSERT” for an inset of a running cap) was a violation of art. 16 of the Textile Regulation) and unfair under sec. 5a of the German Act Against Unfair Competition [Gesetz gegen den unlauteren Wettbewerb – UWG].

The case

The Defendant offered a running cap on sales platforms, indicating the following textile fibre composition:

“SHELL: 100% POLYESTER; WINDSTOPPER@MEMBRANE: 100% POLYESTER; INSERT: 88% NYLON; 12% ELASTANE”

The Plaintiff complained among other things that the use of the English terms “SHELL” (meaning the outer layer) and “INSERT” (meaning the inside) to indicate the textile components of the running cap violates art. 16 of the Textile Regulation and was therefore unfair in the sense of the UWG, in particular under sec. 5a UWG.

The District Court [Landgericht] of Stuttgart upheld the complaint and ordered the Defendant to cease and desist as moved. The Defendant objected to this with its appeal.

The decision

The Stuttgart Court of Appeals confirmed the decision of the District Court of Stuttgart.

The Stuttgart Court of Appeals stated that, even though the wording of the Textile Regulation (art. 16(1) sentence 2, (3)) only requires that the descriptions of textile fibre compositions (referred to in articles 5, 7, 8 and 9 of the Textile Regulation) shall be clearly visible in German before the electronic purchase and does not refer explicitly to art. 11 of the Regulation (which governs the marking and labelling of textile components), ultimately art. 11 of the Textile Regulation merely further develops art. 9 of the Textile Regulation.

Hence, the court was of the view that, by way of the reference to art. 9 and art. 16 of the Textile Regulation, the requirements of art. 11 of the Textile Regulation – i.e. on the labelling of the textile components and their textile fibre contents – must therefore also be considered in the context of art. 16 of the Regulation. The court went on to state that, for this reason, the labelling of textile components and their textile fibre contents should also be clearly visible in German before the electronic purchase. Continue Reading

EU Copyright Directive: Breakthrough

Last night the Commission, the European Parliament and the Council finally agreed the text of the long-awaited draft Copyright Directive. This followed a breakthrough compromise on the liability of platforms for making available user-uploaded content (Article 13). See our earlier blog of yesterday.

The next step will be a vote in the EU Parliament on the agreed text and, assuming it is passed, then it will be published in the Official Journal of the EU. Member States will then have 24 months to implement the new Directive. It remains to be seen whether the UK will be subject to that obligation – which depends on when and how the UK exits the EU.

Once the official agreed text has been published we will report on the detail. In the meantime, you can read the Commission’s Press Release here and the EU Parliament’s Press Release here.

Joint Development and Collaboration Agreements: Your Go-To Guide

Protecting your intellectual property is a challenge, especially when entering into a joint development agreement, or “JDA”. When two or more organizations want to work together to develop or enhance their products, combine or integrate their technologies, or jointly commercialize a new product, they have many choices for documenting their relationship.

If the collaboration is simple and development work minimal, the parties might use standard licensing agreements and purchase orders. If the parties contemplate creating an ongoing business and making substantial investments, creation of a separate joint venture entity may be the best path. In many cases, however, a joint development or collaboration agreement provides the right framework—establishing a set of rules tailored to the relationship without the overhead and complexity of a separate joint venture. This primer outlines key contract points that recur frequently in JDAs and is designed to provide points for consideration and checklists of items for the attorney to consider in preparing and negotiating a JDA, including intellectual property rights arising out of the development work.

The full document can be accessed here: Hogan Lovells – Joint development and Collaboration agreements.

EUIPO to use blockchain in fight against counterfeiting

What has happened?

The European Union Intellectual Property Office (EUIPO) has launched a new forum based on blockchain to combat counterfeiting.

What does this mean?

The Anti-Counterfeiting Blockathon Forum will be built on blockchain technology and will bring together people and organisations to shape and deliver the future anti-counterfeiting infrastructure.

It follows last year’s Blockathon coding competition, which was run by the EUIPO and the European Commission, and is linked to the EU Blockchain Observatory.

The Forum will connect private organisations, enforcement authorities and citizens to support the identification of authentic and counterfeit goods throughout the distribution chain.

It will focus on drafting and defining the anti-counterfeiting use case and related pilot with the ultimate goal of delivering the next level of anti-counterfeiting infrastructure based on blockchain.

The Executive Director of the EUIPO, Christian Archambeau, called on private sector organisations, and all interested individuals to join the anti-counterfeiting forum to help develop and test solutions that would successfully combat the “global plague” of counterfeiting.

“In today’s fast moving world, we need to use the latest technology to keep a reliable record of the origin of goods and their progress through international supply chains. Blockchain’s ability to create permanent and unchangeable records makes it one of the best candidates to deliver results on the ground”, he added.

Next steps

If you want to take advantage of blockchain’s huge potential and disruptive impact, while avoiding falling foul of ever-developing regulatory and legal requirements, visit our Hogan Lovells Engage Blockchain Toolkit.

DSM Watch: Crunch time for the Copyright Directive

Debate on the shape of the draft Copyright Directive between the EU legislative institutions appears this week to be in the final stretch. One of the last bones of contention between the negotiators is the draft’s highly controversial Article 13. A recently leaked document (read it here) provided an insight into the negotiations and the disagreements between Member States on Article 13 within the EU Council. Eventually, these issues were overcome – with an intervention from above – but the question remains: will the Trilogue this week be able to iron all the issues ahead of EU elections in May?

The story so far

The Commission first published its proposal for a new Directive on Copyright in the Digital Single Market (COM(2016)593) on 14 September 2016. The initial goal was not to overhaul the fundamental principles of European law in this area (laid out in the 2001 InfoSoc Directive Directive 2001/29), but to amend and enhance the current framework, and, in EU Commission language, provide an additional set of rules to make copyright fit for the digital age.

On 25 May 2018, after months of deliberations, the Council agreed on a common position regarding the proposal (read our blog here). A couple of months later, the European Parliament also hammered out compromise wording based on the initial Commission draft (read more about it here). That led to the start of the three-way negotiations (also known as trilogue) between the representatives of the Council, and Parliament, with the Commission in a mediating role). Five trilogue sessions were held in late 2018, with a further meeting scheduled for mid-January 2019. That was postponed on short notice because of a disagreement between France and Germany over an exception in the Article 13 proposal in relation to SMEs.

While France wanted a uniform regime for the mitigation of liability under Article 13, Germany advocated for softer requirements for start-ups. The other Member States agreed the Franco-German compromise during a Council meeting ahead of the trilogue, on 8 February, but apparently without unanimity. Reportedly (according to MEP Julia Reda), 8 Member States opposed the deal (Italy, Poland, the Netherlands, Sweden, Finland, Luxembourg, Malta and Slovakia).

Article 13 Council compromise: a limited exemption for SMEs Continue Reading

To ‘Bland’ or Not To Bland? Trademark Implications

Companies are simplifying, or “blanding,” their brands dropping unique fonts, words, and design elements left and right in favor of a pared down, sans-serif font popular in Silicon Valley, but does this drop trademark protections in the process?

You’ve seen it in the ads you encounter on your way to work, on television, and probably in the applications on your smartphone. The simplification. The sleekness. The smoothness. Simplification, or “blanding,” through the softening and rounding of lettering while dropping or minimizing any accompanying or surrounding designs, is trending. But the rush to simplify leaves in its wake a sea of logos that look remarkably alike. Is this new trend towards blanding the right move?

Blanding may offer short-term marketing success, but the long-term effects on a brand’s inherent value, purpose and enforceability could be consequential. The true measure of a brand is its ability to break through the static of the marketplace to generate a powerful consumer response. Dispensing with a unique look in favor of a common unadorned font threatens a brand’s ability to serve that basic function.

Uniqueness Strengthens Protections

It’s a fundamental tenet of trademark law that the more distinctive, unique, or unusual the brand, the broader its scope of protection against copycats, competitors, or squatters.

Invented words or regular words used arbitrarily (i.e., think KODAK for cameras or APPLE for computers) are afforded the broadest scope of protection, whereas marks that describe what their goods, features, or purpose are (i.e., ABSORBENT for paper towels) receive the least.

Continue Reading

No Deal Brexit and Copyright – Part 2: Orphan Works

Towards the end of last year the UK government published draft legislation on copyright, which will come into force if there is a no-deal Brexit. We are publishing a series of blogs on the impact of the Copyright SI. In this blog we look at the impact on orphan works.

Purpose of the Copyright SI

On 26 October 2018, the UK government published a draft version of a statutory instrument (Copyright SI) and explanatory note together with guidance issued by the UK Intellectual Property Office (IPO) which explain the changes which will be made to UK copyright law in the event of a ‘no deal’ Brexit. The purpose of the Copyright SI is to correct any deficiencies in the UK Copyright, Designs and Patents Act 1988 (CDPA) arising as a result of Brexit and to manage the impact of a ‘no deal’ Brexit on any cross-border copyright mechanisms (such as the ‘country of origin’ principle for clearing copyright works in satellite broadcasts). The government’s approach is to preserve the status quo where possible and give continued effect to cross-border mechanisms (even where there is no guarantee of reciprocity from the EU). Unless the UK and the EU reach a deal on these issues (these issues not being covered by the draft Withdrawal Agreement published on 14 November) the Copyright SI will come into force on exit day.

Impact on the Orphan Works regime

The EU Directive on certain permitted uses of orphan works (Directive 2012/28/EU) (the Orphan Works Directive) introduced a specific exception to copyright infringement for certain institutions, including publicly accessible libraries, educational establishments or museums, archives and public service broadcasters (‘cultural heritage institutions’ or CHI’s) to allow them to copy ‘orphan works’ for the purposes of digitisation, restoration, indexing and making them available on their websites. The amendments remove this exception from the CDPA. The effect of this is that UK CHI’s will no longer be able to rely on the orphan works exception to copy orphan works in their collections and make them available online throughout the EEA. However, the UK’s own licensing scheme for the use of orphan works will still apply. Under the UK scheme, any person wishing to use an orphan work can apply to the Controller-General of Patents, Designs and Trade Marks for a licence to copy or use the work in the UK.

Part 1: No Deal Brexit – Copyright and Broadcasting and Online Content Services is available here.


For more information on the UK orphan works scheme contact Alastair Shaw or Penelope Thornton in our IPMT practice. For more information on Brexit and IP and our Brexit taskforce, go to our dedicated Brexit Hub.

iPunkt recap… Will CJEU follow Advocate General on unauthorised sampling opinion?

This post was originally published in iPunkt, our German language newsletter and has now been translated for LimeGreen IP News.

In December 2018, CJEU Advocate General Szpunar took the view that the reuse of a sound sequence in a new song (referred to as sampling) without the author’s permission violates copyright law (case C-476/17 – Moses Pelham et al.). According to the Advocate General, it must not be assumed that artistic freedom prevails over the right to property of phonogram producers.

The dispute relates to the taking of a two-second sound sequence from the song “Metall auf Metall” by the band “Kraftwerk”, which was originally released in 1977 ). Almost twenty years later, the artist Moses Pelham, among others, took the sound sequence and used it for the production of the track “Nur mir” by Sabrina Setlur. The sequence was slowed down by 5% and then repeated in a loop. No licence was obtained for the sample.

The Plaintiffs regarded this as an infringement of their related right as a phonogram producer (see our earlier post.

Opinion:

Advocate General Szpunar took the view that the use of a sample without consent constitutes an infringement of phonogram producers’ right of reproduction. He stated that a distinction must be made between the protection of the recorded work and of the phonogram. Spuznar deemed that a phonogram is a fixation of sounds which is protected, not by virtue of the arrangement of those sounds (i.e. of the work), but rather on account of the fixation itself. In his opinion, this means in particular that these areas of protection are not identical.

On this basis, the Advocate General concluded that the producer of the phonogram also has the right to generate income not only by selling copies, but also by authorising sampling.

The Advocate General was also of the view that the artist cannot justify the sampling on the basis of the right of free use or the right of quotation. He stated that the exceptions and limitations in Directive 2001/29 are exhaustive. In his opinion, there is a degree of latitude in the manner in which the barriers of art. 5 of the InfoSoc Directive are transposed into national law, but the right of free use is not provided for in art. 5 of the InfoSoc Directive. The Advocate General found that the artist cannot invoke the right of quotation as there is no apparent intention of triggering an interaction with the original work; in particular, the extract must be incorporated without modification and the source must be indicated, which is not the case here. Continue Reading

German Trade Mark Modernization Act implementing the EU Trade Marks Directive: The highlights

The amendment of the German Trade Mark Act by way of the Trade Mark Modernization Act (MaMoG) entered into force on 14 January 2019, implementing a range of obligatory and optional provisions of the EU Trade Mark Directive 2015/2436 into German law. In addition to some changes of rather editorial nature, the MaMog also introduces a number of genuine reforms for the German national trade mark system. Let’s take a look at the most relevant changes to the legal practice.

Requirements for protection

Under the MaMoG, register marks no longer have to be capable of being represented graphically. It is sufficient if they can be determined clearly and precisely (sec. 8 para. 1 of the German Trade Mark Act [Markengesetz – MarkenG]. This change means that in particular the registration of modern types of trade marks such as sound marks, multimedia marks, holograms and other types of trade marks in suitable electronic formats is made easier. In the future, new absolute grounds for refusal, including protected geographical indications, geographical designations of origin and traditional terms for wines and specialities, as well as protected plant variety denominations, will have to be considered (sec. 8 para. 2 nos. 9–12 MarkenG).

Comments by third parties during the application procedure

Third parties not involved in the application procedure can in future submit written observations during the application procedure to show why registration of the trade mark in question ought to be denied ex officio (sec. 37 para. 6 MarkenG).

Introduction of the certification mark Continue Reading