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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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Annual Review ELZABURU 2019

Annual Review ELZABURU 2019

Following a delay caused by the lockdown situation in Spain as a result of the global pandemic, but with the usual sense of pride, we present to our clients, friends and colleagues the ninth edition of ELZABURU’s Annual Review of European case-law in the field of industrial and intellectual property.

Annual Review ELZABURU 2019  

When the Annual Review was in print, our Firm was grieving the passing of its President, Alberto Elzaburu, who proudly presented the earlier editions. We wish to dedicate this edition to him, with the photograph displayed in this Annual Review.

Our regular readers will note that this edition reflects ELZABURU’s change of corporate image, which symbolises the Firm’s vocation for adapting to the new demands of a marketplace that is subject to constant technological and social change.

On this occasion, the Annual Review includes 31 articles on rulings by the Court of Justice of the European Union, the Spanish Supreme Court, the European Union Trade Mark Court in Alicante, and Spain’s Provincial Courts of Appeal. This is all made possible by the selfless and enthusiastic participation of a large number of the Firm’s professionals, to whom we would like to express our sincere gratitude.

We hope that those interested in legal developments in Europe in the field of industrial and intellectual property will enjoy this simple and impartial analysis.

 

Annual Review in PDF format

Annual Review in e-book format

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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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The Beijing Treaty: A step forward in the protection of audiovisual performances

Tratado de Beijing: un paso al frente en la protección sobre obras audiovisuales

There are many circumstances that are to mark this unexpected lockdown stage which has taken the world by storm. The common paralysis throughout the States suffering the COVID-19 pandemic is a reminder, despite the dissenting voices, of the importance of globalisation, which has allowed for a response to the crisis by these States which, individually, would have been much slower and complex.

In the middle of this economic and social paralysis and as a tireless discipline, Law has prevailed as always, if anything with even more frantic activity. The Beijing Treaty on Audiovisual Performances (BTAP, hereinafter the “Treaty”) came into force on 28 April in the first thirty contracting parties (the minimum amount required for this). It was a historic milestone in the area of rights related to copyright. From now on, its binding nature will take effect three months after the ratification by or accession of each new State included. Switzerland has been the first to increase this list.

The Beijing Treaty: A step forward in the protection of audiovisual performances

 

For the first time, an international instrument confers express protection to performing artists for fixations of their work on an audiovisual medium, acknowledging their right to decide the time and manner in which their audiovisual works are used abroad, while also to have their share in the profits obtained by their exploitation, even in the digital environment. Up to now, only pure sound fixations enjoyed this protection (see the WIPO Performances and Phonograms Treaty – WPPT – approved in 1996 and in force since 2002).

With this Treaty, any performance of literary or artistic works or expression of folklore is covered by intellectual property, independently from its nature or medium, including both works that are fixed and unfixed (live performances), acknowledging the creative activity of these performers in the same way as with regard to musicians and authors.

Access the full document on the Treaty.

 

Article previously published at Kluwer IP Law Copyright Cases

Autor: Sara Isabel Tortosa

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