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Not possible to obtain a SPC for a new therapeutic application of an old active ingredient

CJEU judgment of 9 July 2020 (C-673/18 Santen)

One of the requirements to obtain a Supplementary Protection Certificate (“SPC”) for a medicinal product is that the marketing authorisation (“MA”) for the product for which the SPC is sought must be the first authorisation to place the product on the market as a medicinal product (Article 3(d) of Regulation EC No. 469/2009). The interpretation of this requirement has for some time generated considerable debate in legal doctrine and case-law, particularly following the CJEU’s judgment of 19 July 2012 in case C-130/11 Neurim. In said judgment, the CJEU found that the existence of an earlier MA for a veterinary medicinal product did not preclude the grant of a SPC for a different application of the same product

Not possible to obtain a SPC for a new therapeutic application of an old active ingredient  

However, after that judgment the following doubts arose:

  • Did this interpretation only apply to cases where the first MA referred to a veterinary medicinal product and the second to a human medicinal product? or would it also extend to cases of new indications or new uses of active ingredients whose first MA referred to medicinal products of the same kind (human or veterinary)?
  • Would it also extend to cases of new formulations of active ingredients whose first MA referred to medicinal products of the same kind (human or veterinary)?

The CJEU provided an answer (in the negative) to this second question in its judgment of 21 March 2019 in case C-443/17 Abraxis: SPCs cannot be granted for new formulations of old active ingredients.

The issue of the first question has now been resolved by the CJEU in its judgment of 9 July 2020 in the above-mentioned Santen case. Again, the court answers in the negative: it is not possible to grant a SPC for a new therapeutic application of an old active ingredient. Below is a summary of the national proceedings that led to this judgment and of the reasoning followed by the CJEU in its decision:

The main proceedings involved the pharmaceutical company Santen and France’s National Industrial Property Institute (“INPI”). Santen, a pharmaceutical laboratory specializing in ophthalmology, was the holder of, on the one hand, a patent protecting an ophthalmic emulsion in which the active ingredient was ciclosporin and, on the other, a MA for a medicinal product marketed under the name “Ikervis”, the active ingredient of which was ciclosporin, used to treat severe keratitis in adult patients with dry eye disease. On the basis of that patent and MA, Santen filed an application with the INPI for a SPC for the aforementioned medicinal product. However, the INPI rejected the application, finding that the MA in question was not, for the purpose of Article 3(d) of Regulation EC No. 469/2009, the first MA for ciclosporin: a MA had been issued in 1983 for a medicinal product marketed under the name “Sandimmun”, which also had ciclosporin as its active ingredient. “Sandimmun” was indicated for preventing the rejection of solid organ and bone marrow grafts and for other therapeutic uses such as the treatment of endogenous uveitis, an inflammation of all or part of the uvea, the middle part of the eyeball.

Santen appealed the rejection and it was brought before the Court of Appeal in Paris, the court that referred the matter on which the CJEU has now issued a preliminary ruling.

The CJEU’s judgment is based on the following reasoning:

  • The key to determining whether a SPC can be granted for a new therapeutic application of an active ingredient for which authorisation was issued in the past in respect of another therapeutic application, is whether the products that are the subject of the past MA and the new MA can be understood to be different due to the fact that they are intended for different therapeutic uses.
  • The text of Regulation EC No. 469/2009 defines the concept of “product” in relation to an active ingredient, not in relation to a specific therapeutic application of an active ingredient. It follows that the fact that an active ingredient is used for a new therapeutic application does not make it a “different” product when it has been used for an already known therapeutic application.
  • Therefore, Article 3(d) of Regulation EC No. 469/2009 must be interpreted as meaning that it is not possible to consider a MA to be the first MA of a product when it refers to a new therapeutic application of an active ingredient that has already been the subject of another MA for another therapeutic application.

With this judgment the CJEU overturns the Neurim doctrine, opting for a strict interpretation of the requirement of Article 3(d) of Regulation EC No. 469/2009. This ruling will not have been well received by the pharmaceutical industry, which has seen a restriction on the opportunities for securing extended protection of patent rights for new medicinal products consisting of a new therapeutic application of an old active ingredient. However, as the CJEU points out, the intention of the EU legislature was “to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product”.


Author: María Cadarso

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Is a folding bicycle an intellectual work protected by copyright?

Bicicleta Brompton plegada

After the Judgement by the CJEU of 11 June 2020 in the Brompton Case (C 833/18) the answer, as the song goes, is blowing in the wind. This is not surprising.

Let us recall the case. Brompton is an English company that markets a folding bicycle, sold in its current form since 1987, which had been protected as a patent due to its particular technical features: the bicycle can have three different positions (a folded position, an unfolded position and a stand-by position) enabling the bicycle to stay balanced on the ground.

Bicicleta Brompton abierta Bicicleta Brompton plegada

Once the patent rights expired, Brompton brought an action against the company Get2Get, on grounds of copyright infringement, for marketing a bicycle whose appearance is visually very similar to that of the Brompton bicycle and which may fold into the three positions mentioned in the preceding paragraph.

The question is, therefore, whether an object that is constrained by its technical characteristics, to the point that it was protected as a patent, can constitute an intellectual work. The CJEU returns the matter to the national court but highlights some important points.

For the Court it is true that the shape of the cited bicycle is necessary to achieve a particular technical effect, namely, the ability of that bicycle to fold into three positions, one of these enabling it to stay balanced on the ground. However, the national court must ascertain whether, notwithstanding this circumstance, the bicycle constitutes an original work resulting from an intellectual creation.

In this respect, the judgment warns that this is not the case where the realisation of a subject matter has been dictated by technical considerations, rules or other constraints which have left no room for creative freedom or room so limited that the idea and its expression become indissociable. Where the shape of the product is solely dictated by its technical function, that product cannot be covered by copyright protection.

In order to verify this, the national court must determine whether, through that choice of the shape of the product, its author has expressed his creative ability in an original manner by making free and creative choices and has designed the product in such a way that it reflects his personality.

At this point, the Court adds that the existence of other possible shapes which allow the same technical result to be achieved is not decisive in assessing the factors which influenced the choice made by the creator. Likewise, the intention of the alleged infringer is irrelevant in such an assessment.

As regards the existence of an earlier, now expired, patent in the case in the main proceedings and the effectiveness of the shape in achieving the same technical result, these factors should be taken into account only in so far as they make it possible to reveal what was taken into consideration in choosing the shape of the product concerned.

The Court reaches the conclusion that Articles 2 to 5 of Directive 2001/29 must be interpreted as meaning that the copyright protection provided for therein applies to a product whose shape is, at least in part, necessary to obtain a technical result, where that product is an original work resulting from an intellectual creation, in that, through that shape, its author expresses his creative ability in an original manner by making free and creative choices in such a way that the shape reflects his personality, this being for the national court to verify, bearing in mind all the relevant aspects of the dispute in the main proceedings.

In summary, it seems clear that the limits setting the boundaries between intellectual work and other industrial property rights (patents, designs, trademarks) remain unclear to a certain extent and that, in practice, national courts continue to have a wide scope of discretion in spite of, or thanks to, the criteria, so precise yet so ambiguous, laid down by the CJEU.


Author: Antonio Castán

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European Union Public License: a great option for open source projects undertaken in the EU

European Union Public License: una gran opción para proyectos de código abierto desarrollados en la UE

The European Union Public Licence (“EUPL”) is an open source licence approved by the European Commission in 2007, which was specifically designed to adapt it to the legal framework of the European Union.

European Union Public License: una gran opción para proyectos de código abierto desarrollados en la UE  

Why was it needed?

Free/open source software licences originated in the United States. Thus, the common-law system has influenced the wording of the first open source licences and later licences. This has made the interpretation and application of the clauses of such licences within the framework of continental European copyright law problematic in some cases.

For example, one of the most significant differences between these two systems is that all rights of the owner of a work are transferable to third parties under US copyright law, whereas continental copyright law does not permit the transfer of the moral rights in the work, which are inalienable and inherent to the author.

The European Commission issued a study on open source licences for software developed by the Commission at the end of 2004, which highlighted that the existing licences at that point in time did not satisfy certain requirements for the European institutions. Specifically, the issues concerned a lack of specification of applicable legislation and jurisdiction, warranty and liability disclaimers, copyright terminology not adapted in line with European practice, and legal validity in different languages.

Therefore, notwithstanding the large number of open source licences available (more than 300), the European Commission could not find any licence that was suitably adapted to the developments it wanted to carry out and it opted to create the EUPL. The first version was published in 2007, and in 2009 the Open Source Initiative (OSI) certified it as an “open source” licence, having deemed it in compliance with its principles.

The latest version of the EUPL, version 1.2, was updated by means of the Commission’s Implementing Decision (EU) 2017/863 of 18 May 2017, which may be accessed via the following link.

Access the full document on open source licenses.


Author: Agustín Alguacil

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Amazon not liable for trademark infringement in storing goods offered and sold by third parties

Amazon no infringe marcas ajenas al almacenar productos ofrecidos y vendidos por terceros, según el TJUE

In December 2017, the Court of Justice of the European Union ruled that from the standpoint of the rules on competition, the bar imposed by the company Coty Germany on the members of its selective distribution network, prohibiting them from offering its luxury perfumes on the Amazon e-commerce platform, was lawful.

Amazon not liable for trademark infringement in storing goods offered and sold by third parties  

On 2 April of this year, the CJEU ruled on a new matter referred for a preliminary ruling (case C-567/18) concerning the sale of Coty’s perfumes through the aforementioned platform. However, on this occasion, Coty had brought its complaint directly against Amazon, and the decision went against its interests.

Coty Germany had brought an action against Amazon before the German courts, arguing that Amazon was infringing its trademark rights by storing Davidoff brand perfumes in which its trademark rights were not exhausted. The storage in question formed part of the service provided by Amazon to third-party sellers that were offering goods for sale in the “Amazon Marketplace” section of Amazon’s website in Germany.

The complaint was dismissed and, with Coty having lodged an appeal against the decision on a point of law, the German Federal Court of Justice (Bundesgerichtshof) referred a question to the CJEU for a preliminary ruling, seeking clarification as to whether said storage constituted use of the trademark within the meaning of Article 9 of the Regulation on the European Union Trade Mark. Specifically, it questioned whether it came under the example of use mentioned in Article 9(3)(b) of Regulation No. 2017/1001, which provides for prohibiting third parties from “offering the goods, putting them on the market, or stocking them for those purposes”.

In its ruling on the matter, the Court of Justice first of all pointed to its case law holding that on e-commerce platforms third-party trademarks are used by the sellers of the goods and not by the operators of those platforms (judgment of 12 July 2011, L’Oreal, C-324/09).

With respect to the storage service Amazon provides to third parties who sell goods on its platform, the Court stated that according to the information provided by the referring court, those goods were not offered or put on the market by Amazon itself but by the third-party sellers. It further stated that it follows from this circumstance that Amazon does not use the trademarks in its own commercial communication. Therefore, Article 9 of the Regulation is not applicable to Amazon.

Lastly, the CJEU stated that the above does not preclude the examination of the platform operator’s conduct with respect to the trademarks of third parties from the standpoint of other rules of law, specifically Article 14(1) of Directive 2000/31 on certain legal aspects of information society services or Article 11 of Directive 2004/48 on the enforcement of intellectual property rights. However, since this matter had not been raised by the referring court in this case, the Court of Justice refrained from conducting such an examination, notwithstanding Coty’s petition in this regard.

In summary, the Court of Justice rejects that Amazon may be held directly liable for trademark infringements committed by sellers that use its online sales platform, not even when it stores the infringing goods. Nevertheless, it does not rule out the possibility that the owners of infringed trademarks could request measures against Amazon through application of the rules in the aforementioned directives. In this regard, we must consider the precedent of the aforementioned judgment of 12 July 2011, in which this issue was examined in relation to the eBay platform.


Author: Carlos Morán

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Spain in 3rd place among the top ten EU countries regarding detention of counterfeit products at customs in 2018

Innovation and creativity are the drivers of our economy. Therefore, it is important to provide rightholders with the certainty that their inventions will be duly protected. The competitiveness of European companies depends on it.

The enforcement of intellectual and industrial property rights by European customs is a priority for the European Commission and for Member States.

The European Commission published the “Report on the EU customs enforcement of intellectual property rights: Results at the EU border 2018” on 24 September 2019. The report shows that the number of interceptions of counterfeit goods imported to the EU increased in 2018 as a result of the large quantity of small packages in express postal traffic. The figures for detentions of these shipments increased from 57,433 in 2017 to 69,354 in 2018, although the total amount of articles detained (almost 27 million in 2018, with a market value of almost 740 million euros) fell by 15% compared with 2017.

The main categories of items detained were cigarettes (15% of the total amount of items detained), followed by toys (14%), packaging material (9%), labels and stickers (9%), and clothing (8%). Products for daily use, such as body care articles, medicines, toys and electrical household appliances, constituted almost 37% of the total amount of articles detained.

China remained the principal country of provenance of goods infringing intellectual property rights. North Macedonia was the main country of provenance for counterfeit alcoholic beverages. Turkey was the main source for other beverages, perfumes and cosmetics. EU customs detected a high number of fake watches, mobile telephones and accessories, ink and toner cartridges, CDs/DVDs, labels, tags and stickers from Hong Kong (China). India was the main country of provenance for computer equipment, Cambodia for cigarettes, and Bosnia-Herzegovina for packaging material.

The number of cases of detentions in air and sea transport have fallen, while the cases of detentions in courier and postal shipments increased, the latter amounting to 84% of the total number of cases, consisting mainly of consumer goods purchased via e-commerce. Sea transport remains in first place (54.29%) in terms of the means of transport with the highest number of articles detained.

Spain is in third place among the top ten European countries, which jointly account for 90% of all detention cases, with a total de 3,934 cases in 2018 compared with 3,740 cases in 2017 (+ 5%). However, Spain holds the 11th position in the ranking of articles detained, with 1,305,972 articles detained in 2018 in comparison with 1,776,405 articles in 2017 (- 26%), practically level with Belgium in 10th position, with 1,307,944 articles. Spain therefore joins the leading group of the 4 top ten countries in the EU in terms of the number of detention cases and articles detained.

For Spain it will pose a great challenge to maintains its leading position in the EU top ten in relation to customs detention in defence of intellectual and industrial property rights.

Author: Juan José Caselles
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