A CLEAR NO TO NOSECCO! THE HIGH COURT OF JUSTICE OF ENGLAND AND WALES REJECTS THE APPEAL IN A NEW CHAPTER IN THE BUBBLE WAR. THE PROTECTED DESIGNATION OF ORIGIN “PROSECCO” IS AN OBSTACLE TO THE REGISTRATION OF THE TRADEMARK “NOSECCO”.

02/07/2020

By decision of 24 June, the High Court of Justice of England and Wales confirmed the previous rejection of the application for the trademark Nosecco of the Intellectual Property Office of the United Kingdom, considering the interference with the protected designation of origin “Prosecco”, under EU Regulation No 1308/2013, and also considering the risk that the sign could mislead the English public.

 

The contested trademark application
The well-known French company Les Grand Chais de France, producer of a non-alcoholic sparkling wine, had filed an application in January 2018 for the following international trademark for non-alcoholic wines:

The opposition procedure
The Italian Consortium for the Protection of the Controlled Designation of Origin Prosecco has successfully filed an opposition against the above trademark application before the Intellectual Property Office of the United Kingdom: the office pointed out that EU Regulation no. 1308/2013 shields protected designations of origin explicitly from “any misuse, imitation or evocation” and this also when the actual origin of the product is indicated (as happened in this case). The UK office also stressed that the term “evocation” does not require any risk of confusion: for having an evocation it would be sufficient to have a link to the protected term designation of origin to convey a new message to the consumer. Moreover, the trademark would be deceptive for the consumer who could well expect that the product thus indicated would, in some way, result from the elaboration of an authentic Prosecco.

The appeal
The decision was appealed by the French company. The combination of the initial negation ‘No’ with the adjective ‘secco’ (= “dry” in Italian language) would have the meaning of a witty indication for a beverage which is not dry and therefore sweet. The starting point of the argument was that knowledge of the Italian term ‘secco’ could be taken for granted, even by an English-speaking public. If anything, the imaginative creation “No secco” would be considered as a legitimate parody of the term Prosecco. The play on words could therefore also be interpreted as a “no” to “prosecco”, an interpretation that would distance the consumer from the protected term. To describe this argument the appellant had used the suggestive term “teach away”, and thus the expression known in the patent field to highlight the irreconcilable conceptual distance and different direction between two ideas. The mentioning that there would be “many reasons why people choose non-alcoholic beverages, including reasons of religion, health, low calorie requirements, legitimate participation in motorized traffic”, the French appellant had also implicitly suggested the possible relevance of fundamental rights to the present case. Moreover, according to the appellant, the decision of rejection was unjustifiably based on a “presumed consumer perception” since it was not considered necessary to have concrete evidence of the latter.

The decision of the High Court of Justice of England and Wales
The High Court of Justice of England and Wales rejected the appeal, confirming the previous decision: what matters is not the intention of the creator of the sign but, as correctly observed by the Office, the alleged public perception. The first association of the public, in the case of the sign “Nosecco”, would be the well-known “Prosecco”, while the possible second thought would derive from the denial, namely that it is not a Prosecco and that it is not a dry-tasting drink. There would therefore be no room for the application of a “teach away” doctrine in the field of distinctive signs. It was also reaffirmed that the application of the criterion of “presumed consumer perception”, even without resorting to ex officio technical advice, must be considered to be confirmed by settled case-law of the Court of Justice of the European Union.

Note
From a systematic – conceptual point of view, the decision of the High Court of Justice of England and Wales is not surprising: the text of EU Regulation 1308/2013, which expressly prohibits any “evocation”, has often been applied with severity even in the previous case law of the Court of Justice concerning the conflicts between the signs Cognac / Konjakkia; Gorgonzola / Cambozola or Calvados / Verlados. The application of the criterion of “presumed public perception”, to be determined directly by the Judge, can also be based on established case law. Nevertheless, in order to correctly determine the perception of the public, it will be necessary to observe very carefully changing customs. The present dispute can be framed in a broader context in which it can often be observed how the use of signs for non-traditional food and drink clashes with historical-traditional signs. The ever-increasing demand for new types of food, capable of satisfying increasingly different and diversified demands, sometimes supported by aspects such as religion and health, and on the other hand the possibility of enjoying food from increasingly diverse origins, will inevitably change the type of perception that the consumer will have in relation to the signs used in these areas.

Tankred Thiem


FUNCTIONAL SHAPES AND HEAP OF PROTECTIONS: CGUE ADMITS CUMULATION BETWEEN PATENT AND COPYRIGHT

16/06/2020

By its recent decision of 11 June 2020 in Case C-833/18, the Court of Justice of the European Union (CJEU) confirmed that a certain shape, even if already covered by patent protection, can also be protected by copyright if the requirements for protection are fulfilled. In particular, according to the CJEU, even the shapes (at least in part) necessary to achieve a technical result may be sufficiently “creative” to obtain copyright protection, even if already covered by patent protection (now expired).

 

The proceedings before the CJEU
The manufacturer of a well-known folding bicycle applied to the Business Court in Liège, Belgium, for a declaration of infringement of its copyright in relation to the product itself by a bicycle with a highly similar visual appearance, manufactured and marketed by a competitor. The shape was characteristic of a folding bicycle capable of taking three different positions (open, stand by and folded while remaining balanced on the ground) and had already been the subject of a patent which subsequently became public knowledge.
The competitor argued that the shape of the bicycle at issue would not be eligible for copyright protection because it needed the technical function (folding mechanism), as confirmed by the existence of a patent for invention (now expired) on the very same shape.
Consequently, the Belgian Business Court has referred to the Court of Justice of the European Union the question whether works whose shape is necessary to obtain a technical result are excluded from the protection granted by copyright and whether, in order to consider a shape to be technically necessary, account must be taken, inter alia, of the existence of earlier patent protection or the existence of other possible shapes which would enable the same result to be achieved.

The CJEU Decision
In answering the questions posed by the Territorial Court, the Court of Justice of the European Union confirmed that, according to the law of the Union, the meaning of “work” consists of two elements: on the one hand, it implies an original object which is an intellectual creation belonging to its author and, on the other hand, it requires an expression of that creation. In relation to the concept of ‘originality’, the CJEU held that it is sufficient for the object to reflect the personality of its author, manifesting the author’s free and creative choices, even if the shape of the object is determined by technical reasons. Obviously, according to the CJEU, a free and creative choice of the author must also be found in the choice of technical solutions. The only limit that meets the protection of copyright on shapes is therefore the assessment of the author’s “creativity”, i.e. whether the creation of an object has been determined by technical reasons, rules or other constraints that have left no room for the exercise of the author’s creative freedom or have left it so limited that the idea and its expression are confused. This regardless of whether there are other possible shapes, i.e. a (expired) patent on the shape itself.

Potential (and expected) competitive implications
The decision made by the CJEU follows on from previous decisions that have admitted the cumulation between the shapes of copyright protection with those of design and patents for invention. The same Court recently ruled that particular types of jeans and sweatshirts, already protected as designs, could also be protected from a copyright point of view if the shape could be determined by creative choice and expression of the author’s personality (see decision of 12 September 2019, case C-683/17 “Cofemel”). However, such an interpretation brings with it clear anti-competitive and possible system-breaking effects that cannot be underestimated (on this point, see below the Opinion of the Advocate General in Case C-833/18).
Indeed, we should not forget that our system is conceived to achieve a proper balance between IP monopolies, aimed at fostering creativity, the development of technological progress and free competition. Increasing the possibility of cumulation of exclusive rights on certain shapes or objects reduces, as a result, the possibility of competitors entering the market, thus increasing the (legal) monopoly on certain shapes. In addition, legitimizing the use of the most extensive copyright protection on certain shapes that should have been the object of design protection and/or patent protection for invention also risks to discourage the use of such types of protection because they are more expensive and complex to obtain (accordingly, see also the ZANON, I modelli di utilità, in Codice della proprietà industriale edited by Adriano Vanzetti, Giuffrè Editore 2013, 1030 ff.). Moreover, it cannot be overlooked how the court’s arguments do not appear completely clear, since the copyright typically creative space does not normally exist when facing a functional choice, which as such is substantially necessary because of the function that is intended to be achieved.
However, the protectionist drift now mentioned does not seem to affect the decisions made by the CJEU on the protection of shape trademarks. In fact, the case law of the Court of Justice has always been opposed to the protection of even partially functional shapes as trademarks, so that the Court specified in Decision C-48/09 (Lego Iuris case) that “when the shape of a product merely incorporates the technical solution developed by the manufacturer of that product and patented by it, protection of that shape as a trade mark once the patent has expired would considerably and permanently reduce the opportunity for other undertakings to use that technical solution” (Par. 46). This is because “in the system of intellectual property rights developed in the European Union, technical solutions are capable of protection only for a limited period, so that subsequently they may be freely used by all economic operators” (Par. 46). It is true that the copyright protection is not perpetual, expiring 70 years after the death of the author, but it is also true that this is a very long period of time, which in many cases completely exhausts the concrete possibilities of exploitation of an invention or a solution.
It is therefore clear that there is a divergence between decisions made by the same Court on the protection of shape in the fields of copyright and shape trademarks, with evidently conflicting reasons. It is desirable, in order to keep the system alive, that the CJEU will harmonise its decisions on the cumulation of shape protections so as to bring back clarity to users.

Alessandro Bura


COVID-19 UND PATENTSCHUTZ: DER AUFRUF DER WHO ZU EINER INITIATIVE FÜR IMPFSTOFFE UND BEHANDLUNGEN

09/06/2020

Letzten Monat hat die Weltgesundheitsorganisation einen Vorschlag der Vertretung Costa Ricas aufgegriffen zur Einrichtung einer Solidaritätsplattform für die gemeinsame Nutzung von Patenten für Wirkstoffe und Vorrichtungen zur Bekämpfung des Covid -19. Angesichts des monopolistischen Charakters gewerblicher Schutzrechte und der vielen verschiedenen gelagerten Interessen wirft der Vorschlage viele Fragen auf. Zu den in Ausgleich zu bringenden Rechten gehören das Recht auf Gesundheit und das der freien wirtschaftlichen Initiative.

 

Initiative der Weltgesundheitsorganisation
Am 18. Mai 2020 befürwortete die Weltgesundheitsorganisation die Initiative zur Schaffung eines “Covid-19 – Intellectual Property Pool”. Der Vorschlag, der vor einigen Wochen von Vertretern des Staates Costa Rica vorgestellt worden war, zielt darauf ab, eine Solidaritätsplattform für den Austausch von Patentrechten, Testdaten und anderen Informationen zu schaffen, die für die Entwicklung von Covid-19-Medikamenten, Impfstoffen und Diagnosemethoden notwendig oder nützlich sind.
Die Initiative ist von der Sorge getragen, dass in naher Zukunft medizinische Produkte gegen Covid-19 für den ärmsten Teil der Weltbevölkerung nicht zugänglich sein werden. Die grundlegende Idee der Initiative ist die Schaffung einer Plattform auf Basis freiwilliger Solidarität unter der Ägide der WHO, um einen gemeinsamen Ansatz von Regierungen, Unternehmen, Universitäten und gemeinnützigen Organisationen zu schaffen. In diesem Zusammenhang erwägt die Weltgesundheitsversammlung – das höchste Entscheidungsgremium der WHO – die Annahme der von der Europäischen Union vorgelegten Resolution. Diese greift den oben erwähnten Vorschlag Costa Ricas auf, der darauf abzielt, weniger entwickelte Ländern Zugang zur Verwendung von Erfindungen sicherzustellen, die in Patentanmeldungen für Arzneimittel oder medizinische Produkte gegen Covid-19 beansprucht werden.
Die Frage ist angesichts des monopolistischen Charakters der Rechte an geistigem Eigentum ziemlich heikel: sie würde eine Ad-hoc-Regelung erfordern, die – obwohl die aufgrund der durch COVID-19 geschaffenen Situation eine Besonderheit darstellt – die allgemeinen systematischen Grundsätze respektieren muss und die die wirtschaftlichen Auswirkungen angemessen regulieren könnte. Es stehen zahlreiche Interessen auf dem Spiel: erstens nationale Interessen, insofern als das ein Medikament oder Impfstoff gegen Covid-19 von staatlicher Seite auch als geopolitischer Wettbewerbsvorteil genutzt werden kann. Zweitens müssen die geistigen Eigentumsrechte der Pharmaunternehmen berücksichtigt werden, denen eine wirtschaftliche Rentabilität der getätigten Investitionen garantiert werden sollte (im Fall von Covid 19 erfolgte eine in der Geschichte der medizinischen Forschung einzigartige Mobilisierung menschlicher und finanzieller Ressourcen). Schließlich sollte die öffentliche Gesundheit als primäres Gut geschützt werden, da es sich um ein Grundrecht handelt, das in allen Verfassungen anerkannt wird.

Wissensaustausch oder Zwangslizenzen für Patente?
Es sind zwei mögliche Wege der internationalen Zusammenarbeit im Kampf gegen Covid-19 zu unterscheiden. Die Staaten könnten zusammenarbeiten, um neue Medikamente, Impfstoffe und Diagnoseverfahren zu entwickeln und herzustellen, auch durch die Zusammenarbeit von öffentlichen Einrichtungen wie Universitäten oder Forschungszentren. In diesem Fall könnte anlässlich des oben erwähnten “Aufrufs” der WHO eine Vereinbarung angestrebt werden, um einen fairen Zugang zu jedem medizinischen Produkt zu gewährleisten, das aus gemeinsamer Forschung resultiert. Alternativ dazu könnten etwaige Schutzrechte des privaten Sektors und deren Verkehr so geregelt werden, dass ihre Nutzung durch die größtmögliche Anzahl von Menschen weltweit gewährleistet ist. Hier ergeben sich verschiedene Möglichkeiten: entweder könnte, wie die WHO es vorschlägt, eine Aussetzung der gesetzlichen Monopolrechte auf die Erfindungen erfolgen, die speziell zur Heilung und Behandlung von Covid-19 bestimmt sind (darüber hinaus sollte eine Unterscheidung hinsichtlich der Ätiologie der Symptome getroffen werden, die Covid-19 mit anderen Pathologien gemeinsam hat), was eine Neugestaltung und Beschränkung dieser Rechte bedeuten würde.
Der Ansatz der Plattform eines freiwilligen Austausches unterscheidet sich von dem von Nichtregierungsorganisationen und akademischen Experten unterbreiteten Vorschlag der Anwendung staatlicher Zwangslizenzen. Letztere stellen eine vom TRIPS – Abkommen der Welthandelsorganisation vorgesehene Möglichkeit dar. Zwangslizenzen erlauben es, unter bestimmten Voraussetzungen patentierte Arzneimittel ohne Zustimmung des Patentinhabers herzustellen oder aus einem anderen Land zu importieren, wenn das importierende Land nicht über die notwendigen industriell-pharmazeutischen Kapazitäten verfügt (sog. Parallelimporte).
Die Zwangslizensierung erfolgt unter verschiedenen Voraussetzungen. Zunächst muss tatsächlich ein nationaler Gesundheitsnotstand vorliegen, so dass ein formeller Antrag an den Patentinhaber auf eine sofortige Erlaubnis zur Herstellung der erforderlichen Arzneimittel gestellt werden kann. Erst wenn dieser seine Zustimmung verweigert, ist der Rückgriff auf das Institut der Zwangslizenz eröffnet. Dies setzt jedoch die Bereitschaft voraus, dem Patentinhaber eine angemessene Gebühr zu zahlen sowie die zeitliche und geografische Begrenzung der Lizenz.
Im Laufe der Jahre haben eine Reihe von Entwicklungsländern als Reaktion auf hohe Arzneimittelkosten auf das Instrument der Zwangslizenzen zurückgegriffen, zum Nachteil der Pharmaindustrie. In diesem Zusammenhang sind zwei Streitigkeiten erwähnenswert: eine in Südafrika (siehe South African Pharmaceutical Manufacturers Association vs. The Government of South Africa, Fall Nr. 4183, 1998, High Court of Pretoria) und die andere in Indien (siehe Novartis AG vs. Union of India (UOI) und Ors. Uol & Ors.; M/S Cancer Patients Aid Association v. Uol & Ors), an der zwei große Pharmaunternehmen beteiligt sind. Letztere hatten die oben genannten Staaten beschuldigt, die Klauseln über die Beschränkung des geistigen Eigentums im TRIPS -Übereinkommen in einer zu weit gehenden Weise umgesetzt und ausgelegt zu haben, wodurch die einschlägigen Verfassungsgrundsätze über wirtschaftliche Freiheiten verletzt worden seien. In den streitigen Auseinandersetzungen betonten die nationalen Gerichte schließlich die sozialen Rechte und andere Grundrechte wie das Recht auf Leben, Gesundheit und Menschenwürde und legitimierten damit die Wirtschaftspolitik dieser Länder bei der Anwendung der im TRIPS-Übereinkommen enthaltenen Klauseln zur Beschränkung des geistigen Eigentums.

Das (derzeitige) Widerwillen westlicher Länder, sich der Plattform des Austausches anzuschließen
Der formelle Start der Austauschplattform und damit der Aussetzung der Anwendung gewerblicher Schutzrechte für pharmazeutische oder medizinische Produkte gegen Covid-19 war für den 29. Mai 2020 geplant. Nach den bisherigen Mitteilungen der WHO waren die ersten Länder, die die Initiative unterstützten Ägypten, Argentinien, Bangladesch, Barbados, Belize, Brasilien, Bhutan, Chile, Dominikanische Republik, Ecuador, El Salvador, Honduras, Indonesien, Libanon, Luxemburg, Malaysia, Malediven, Mexiko, Mongolei, Mosambik, Norwegen, Oman, Pakistan, Palau, Panama, Peru, Portugal, St. Vincent und die Grenadinen, Sri Lanka, Südafrika, Sudan, die Niederlande, Osttimor, Uruguay und Simbabwe. Noch immer fehlen die westlichen Länder (die Mehrheit der EU- und US-Mitgliedstaaten) – sowie Israel, China, Japan, Indien – in denen große Pharmaunternehmen ansässig sind. Die aktuelle Liste enthält daher viele Entwicklungsländer, die über keine besonders entwickelten technologischen, Produktions- oder Vertriebskapazitäten verfügen.

Maßnahmen einzelner Staaten gegen das Covid-19-Impfstoffmonopol
Im aktuellen Kontext einer globalen Pandemie haben nicht nur die sogenannten “Entwicklungsländer” das Instrument der Zwangslizenzen angewendet. Im Zusammenhang mit Covid-19 Staaten bewegen sich Staatem wie Deutschland, Israel, Ecuador, Brasilien und Chile ebenfalls in Richtung Zwangslizenzen für Patente, während das Vereinigte Königreich und Kanada die Entkriminalisierung der Nutzung von im Zusammenhang mit dem Covid-19 stehenden Patenten vorgesehen haben, was für diese Patente die Beseitigung des Straftatbestands der Patentverletzung bedeuten würde. Der Zweck der Zwangslizenz wäre es hingegen, einen fairen Zugang zu Medikamenten für die Pandemiebehandlung zu gewährleisten. Einige Rechtssysteme, darunter das italienische, erlauben es dem Staat, jedes Patent aus Gründen der öffentlichen Nützlichkeit gegen eine an den Inhaber des gewerblichen Schutzrechts zu zahlende Entschädigung in Besitz zu nehmen. Es handelt sich um ein echtes Enteignungsverfahren, mit dem durch Aufhebung des gesetzlich vorgesehenen Monopols eine Solidarität des Patentinhabers erzwungen wird. Es wird jedoch vermutet, dass Pharmaunternehmen in der gegenwärtigen Situation daran interessiert sein könnten, freiwillig, unentgeltlich oder auf jeden Fall in “sozialverträglicher” Weise Exklusivrechte an Medikamenten oder Impfstoffen gegen Covid-19 zu gewähren, dank des enormen Imagegewinns, zu dem eine solche Maßnahme voraussichtlich beitragen würde.

Das Verfahren der Enteignung des Patents für nationale Gebrauchsmuster in Italien
Artikel 141 Abs. 1 des italienischen Gesetzbuches zum Schutz geistigen Eigentums sieht vor, dass gewerbliche Schutzrechte, mit Ausnahme von Markenrechten, vom Staat im Interesse der militärischen Landesverteidigung oder aus anderen Gründen des öffentlichen Nutzens enteignet werden können.
Der Staat kann einerseits das Recht als Ganzes enteignen, aber er kann sich auch das Recht nehmen, die Erfindung im nationalen Interesse und für einen bestimmten Zeitraum zu nutzen.
Der zweite Absatz spezifiziert, dass die Enteignung auf das Nutzungsrecht für die Bedürfnisse des Staates beschränkt werden kann, vorbehaltlich der Bestimmungen über Zwangslizenzen, soweit diese kompatibel sind.
Die nationale Gesetzgebung regelt die Enteignung gewerblicher Schutzrechte nicht im Detail und ist bisher noch nie Gegenstand der Rechtsprechungspraxis gewesen. Jedenfalls geht aus dem Wortlaut des Artikels 141 hervor, dass die Enteignung gewerblicher Schutzrechte an bestimmte Bedingungen geknüpft ist.
Die Enteignungsmaßnahme wird per Präsidialerlass und infolge eines recht komplexen, gesetzgeberischen Verfahrens erlassen. Konkret erfolgt die Enteignungsanordnung per Erlass des Präsidenten der Republik auf Vorschlag des zuständigen Ministers im Einvernehmen mit den Ministerien für produktive Tätigkeiten, Wirtschaft und Finanzen und nach Anhörung der Stellungnahme der Berufungskommission des italienischen Marken- und Patentamtes. Artikel 194 des zitierten Gesetzes sieht auch vor, dass eine Kopie des Erlasses im Amtsblatt des italienischen Patent- und Markenamtes (UIBM) veröffentlicht wird, solange dem Staat aus der Veröffentlichung kein Schaden erwachsen kann. Darüber hinaus muss der Erlass in den für Zivilverfahren vorgesehenen Formen etwaigen betroffenen Dritten zugestellt werden. Danach erwirbt die öffentliche Verwaltung das Gegenstand der Enteignung bildende Recht und kann es innerhalb der im Erlass festgelegten Fristen und Dauer in Anspruch nehmen. Zuletzt wird der Enteignungserlass vom Patent- und Markenamt in das Register der gewerblichen Schutzrechte eingetragen. Nur bei Enteignungen aufgrund militärischer Notwendigkeit gilt die Geheimhaltung.
Der Präsidialerlass muss eine gerechte Entschädigung zugunsten des Inhabers des gewerblichen Schutzrechts vorsehen.
Deren Höhe wird nach Anhörung der Beschwerdekammer auf der Grundlage des Marktwerts festgelegt. Das Gesetz gibt jedoch nicht die konkreten Parameter vor, anhand derer die Höhe einer solchen Entschädigung ermittelt werden soll. Falls keine Einigung über die Entschädigungshöhe erzielt wird – Art. 143 des Gesetzbuches zum gewerblichen Rechtsschutz sieht vor, dass der Rechtsinhaber dem durch den Erlass festgelegten Wert widersprechen kann – wird dieser von einem Schiedsgericht festgelegt. Dieses muss eine faire Bewertung treffen, wobei der Verlust des aus dem Schutzrecht resultierende Wettbewerbsvorteil berücksichtigt werden muss.
Wie bereits erwähnt, können die Maßnahmen der vollständigen Enteignung oder zwangsweise auferlegter Beschränkungen nur dann ergriffen werden, wenn Gründe des öffentlichen Nutzens vorliegen (abgesehen vom Interesse der militärischen Landesverteidigung).
Daher ist es notwendig zu verstehen, ob ein solcher Bedarf in der gegenwärtigen pandemischen Notsituation entstehen könnte. Die Frage ist keineswegs überflüssig, da bisher kein gesundheitlicher Notstand und keine Krankheit (auch nicht Herz-Kreislauf- oder Tumorerkrankungen, die zahlenmäßig weitaus größere Auswirkungen haben als alle anderen Krankheiten) jemals als Grund des öffentlichen Nutzens anerkannt wurde, der staatliche Eingriffe zur Regelung des Patentschutzes (Aussetzung) rechtfertigen oder die “Solidarität” der Privatwirtschaft erzwingen könnte. Im weitesten Sinne könnte jedes Mittel, das auf den Schutz und die Erhaltung von Leben und Gesundheit des Menschen abzielt, fast per definitionem unter den Begriff des “öffentlichen Nutzens” fallen. Es ist derzeit nicht absehbar, ob der von der WHO vorgenommene Ausruf einer Pandemie die mögliche Enteignung von Patenten auf Covid-19-Medikamente oder Impfstoffe rechtfertigen kann.
Da es keine einschlägige Rechtsprechung gibt, müssen die nationalen Gerichte, falls sich die Frage stellt, diese durch eine wohlüberlegte Abwägung der auf dem Spiel stehenden Interessen lösen, wobei in diesem Fall das Recht auf Privateigentum und wirtschaftliche Initiative (Art. 41 der italienischen Verf.) und das Recht auf Gleichheit und Gesundheit (Art. 3 und 32 Verf.) zu berücksichtigen sind.
Interessant ist, dass eine derartige Beurteilung Gegenstand einer Entscheidung des Verwaltungsgerichts der italienischen Region Latium war, und zwar in einem Fall, der nicht die Enteignung von gewerblichen Schutzrechten an Arzneimitteln, sondern die Dauer von Zusatzzertifikaten betraf (siehe Regionales Verwaltungsgericht Lazio, Abschnitt III vom 30.09.2003, Nr. 7858, in der Online-Datenbank De Jure). Bei dieser Gelegenheit bekräftigte das Verwaltungsgericht der Region, dass Art. 41 der Verfassung “jedoch kein absolutes Persönlichkeitsrecht ist und daher den Grenzen unterworfen ist, die die Verfassung selbst, auch mittels der vom Gesetzgeber regelmäßig vorgenommenen Umsetzung, vorsieht, wobei die offensichtlichen Grenzen der Zumutbarkeit und der substantiellen Gleichheit der Bürger für soziale Bedürfnisse beachtet werden müssen. Im Prinzip sind wirtschaftliche Effizienz und Rechtssicherheit der rechtlichen Beziehungen und des Verkehrs (insbesondere desjenigen von Dauer) zwar geschützte Werte, aber nicht hierarchisch vorherrschend in Bezug auf andere soziale Bedürfnisse. Die Wirtschaft, die nach dem Willen der Verfassung den gesetzlichen Regelungen des ordentlichen Gesetzgebers folgt, soll nicht nur von der Absicht inspiriert sein, unmittelbar wirtschaftliche Ziele zu verfolgen (Produktionssteigerung, finanzielles Gleichgewicht usw.), sondern auch von der Notwendigkeit geleitet werden, den Prozess der sozialen Umgestaltung zu aktivieren und zu begünstigen, dessen Grundzüge in Art. 3 Abs. 2 der Verfassung beschrieben sind”.
In dem zitierten Fall erkannten die italienischen Richter die wirtschaftliche Initiative als einen durch das System geschützten Wert an, hielten sie jedoch in Bezug auf das in Artikel 3 der Verfassung vorgesehene Prinzip der substanziellen Gleichheit für hierarchisch nicht vorherrschend.
Wendet man diese Perspektive auf die gegenwärtige Pandemiesituation an, so könnte im Hinblick auf die Gewährleistung der vollständigen Umsetzung des Prinzips der substanziellen Gleichheit das Recht, allen Bürgern Zugang zum Covid-19-Impfstoff zu gewähren, als ein höheres Recht als das der pharmazeutische Industrie, die den Impfstoff herstellt, auf Erhalt einer Vergütung und des gerechten Gegenwertes geleisteter Investitionen angesehen werden.

Konsequenzen
Unabhängig davon, ob die Entscheidungen in dieser Situation auf supranationaler Ebene getroffen werden (wie bei der WHO-Initiative zur Festlegung einer Aussetzung von Patentrechten oder jedenfalls zur Festlegung eines technischen Ausschusses, der ähnliche Lösungen zum Schutz der weniger glücklichen Teile der Weltbevölkerung vorschlägt) oder ob sie auf nationaler Ebene durch die Aktivierung von Enteignungsmaßnahmen oder die Erteilung von Zwangslizenzen getroffen werden, wird es in jedem Fall notwendig sein, die künftigen Auswirkungen solcher möglichen Initiativen – nicht nur auf rechtlicher Ebene – eingehend zu prüfen. Es wird notwendig sein, ein Gleichgewicht zwischen dem Schutz der Investitionen von Pharmaunternehmen – aber auch von privaten oder öffentlichen Institutionen – und der Verfolgung des betreffenden Ziels, nämlich des leichteren Zugangs zu Behandlung und Impfstoffen zu suchen und zu finden. Damit soll auch sichergestellt werden, dass die Pharmaunternehmen weiterhin in Forschung und Entwicklung investieren, insbesondere im aktuellen Pandemiekontext, und dass die Forschung auch weiterhin privates Kapital anziehen kann. Auch darf eine Solidaritätsinitiative in der gegenwärtigen Situation keinen Präzedenzfall dafür schaffen, die Notwendigkeit des Patentschutzes für pharmazeutische oder medizinische Erfindungen in Frage zu stellen. Die Pandemie stellt – bereits aufgrund ihres Ausrufes durch die WHO – eine atypische, mit keiner anderen vergleichbaren Situation dar, die die Einführung einer besonderen Ausnahme rechtfertigen könnte. Dies darf jedoch keinesfalls ein generelles Prinzip von enormer Bedeutung für die technische, wirtschaftliche und soziale Entwicklung eines jeden Landes, wie das des Patentschutzes für pharmazeutische und medizinischen Erfindungen in Frage stellen, sondern muss im Gegenteil vielmehr zu dessen Bestätigung beitragen.

Luigi Goglia, Camilla Macrì


FOOTBALL CHAMPIONSHIP AND COVID-19: THE RESUMPTION AFTER THE FORCED STOP. THE REASONS TO RESTART

26/05/2020

In these days the possible resumption of the Serie A football championship is under discussion, starting – probably – from next June 20, 2020, and the ways to conclude it (including the possible play-off and play-out) are being considered. Since May 4, the 20 Serie A clubs have been operational again with individual training sessions, while from May 20, collective training sessions have resumed, in full compliance with the protocol of the FIGC (Federazione Italiana Giuoco Calcio), recently validated by the Scientific Technical Committee of Civil Protection, which regulates, among other things, how to manage a possible positivity to Covid-19.

 

As all Italians know, as a result of the Coronavirus emergency, the Football Championship is being suspended from the 27th day, which should have been played on 13-14 March 2020 (the previous day had been played only partially). In fact, the DCPM of March 9, 2020 suspended (initially until April 3, 2020) all sporting events and competitions of any order and discipline, in public or private places (except for events organized by international sports organizations, behind closed doors). The Prime Minister’s Decree required sports associations and clubs to carry out appropriate checks to limit the risk of spreading COVID-19 among athletes, technicians, managers, and all accompanying persons.
The suspension was then extended several times with the following Prime Ministerial Decrees of 1 April 2020, 10 April, 26 April and, most recently, 17 May, which extended the suspension of all championships until 14 June 2020.
Currently, the possible resumption is set for 20 June 2020, but the date has yet to be confirmed and a meeting is scheduled for 28 May between the FIGC, Lega Calcio and the Minister for Youth and Sport, Vincenzo Spadafora, who has declared that he will have to decide “if and when” the sports season will restart. The recovery deadline is crucial, considering that UEFA has recommended the conclusion of all national tournaments by 2 August 2020.

The FIGC Protocol
On 19 May 2020, the FIGC’s protocol for the safe resumption of collective football training was finally validated by the Scientific Technical Committee for Civil Protection, which contains the requirements that clubs must comply with in order to resume training.
First, clubs will have to divide the team into “team groups”, each made up of players, coaches, masseurs, physiotherapists, warehousemen and social doctors. It is no longer obligatory for the players to retire without security, unless a positive person is found in the team group, who will necessarily have to be placed in quarantine. The team group will then be subjected to trustee isolation in an agreed structure and undergo clinical evaluation (swabs every 48 hours for two weeks). No member of the group can have external contact, but everyone can continue to train.
As regards the training methods, group work is allowed, including training matches, which should take place as much as possible outdoors: the sessions in the gym should initially be reduced to a minimum. A distance of at least 2 meters must be maintained in the changing rooms and showers will not be allowed inside the sports facilities.
Finally, the Protocol provides for several specific anti-accounting measures:
• coach and technical staff must wear face mask and maintain a minimum distance of 2 meters;
• players must reach the sports facilities with their own means and comply with the anti-accounting measures;
• club must set up a thermoscanner and a saturator at the entrance of the sports center;
• swabs will be carried out at the beginning of the collective activities, to be repeated every 4 days. The same for serological tests, to be repeated every 14 days.
Currently, all clubs are monitoring professionals and staff with coronavirus tests and screenings. The tests carried out after the resumption of individual sessions had negative results for almost all teams, with the exception of 6 positive cases for Fiorentina, 2 for Parma and 1 for Torino (the subjects as prescribed were placed in isolation). The names of the players were not communicated, for privacy reasons.
The FIGC is already at work preparing the new protocol that will govern future matches.
To the measures specified in the protocol may be added the indications contained in the vademecum of the scientific group of sports doctors of Serie A, sent to the clubs as early as the beginning of March 2020, containing the rules to avoid contagion, including not drinking from the same bottle, not eating in the changing room, storing personal items and clothing in personal bags, throwing paper handkerchiefs or other materials used such as patches, bandages, etc. immediately in the appropriate containers, washing hands thoroughly as often as possible, using special care when using common toilets, encouraging the use of automatic dispensers with disinfectant cleaning solutions, both in the changing rooms and in the toilets, not touching eyes, nose or mouth with unwashed hands, coughing into their arms, cleaning their mouths and noses with a handkerchief, airing all the rooms as often as possible, cleaning tables, chairs, taps, avoiding award ceremonies or other forms of contact with the audience, using a single microphone in interviews to be disinfected each time, avoiding fans.

The critical points of the Protocol
1. Expensive compliance: the protocol has been considered very expensive both logistically and economically, and could therefore be guaranteed with difficulty by Serie B clubs (while Serie C and the amateurs have already confirmed the final stop of their respective championships);
2. Swabs: the number of swabs required, considering the frequency described above, is very high (we are talking about tens of thousands of swabs). Therefore there is a risk that it will be difficult to carry out all the required tests, considering that the Italian Footballers’ Association (AIC) has expressly stated that it does not want to take advantage of preferential lanes for medical and health checks;
3. Criminal risk in the event of contagion: if players and staff members are infected there is a real risk that football clubs will be considered civilly liable and its managers criminally liable. Indeed, according to the “Cura Italia” Decree, contagion from Covid-19 can be considered an accident at work, and clubs may be held liable if they fail to demonstrate that they have adopted all the precautions provided for by law (and not just the FIGC protocol).

The reasons to restart
During the COVID-19 tsunami, many people wondered whether it was necessary or appropriate to restart the football championship, given the risks involved in contact sports. However, statistics elaborated by the Istituto Superiore della Sanità two months after the beginning of the contagion, show that the risks for people under 60 years of age are very low, especially when they do not suffer from any pathology. On the other hand, the stop undoubtedly creates significant economic, legal, social, and psychological problems. Let us start with the latter. Sporting activity is a right of everyone, in particular for athletes who, deprived of the possibility of expressing themselves, could suffer considerable damage, also due – for example – to the fact that their health and performance conditions could worsen because of time passing, and particularly in situations of inactivity, to the point that in certain cases some careers could be permanently impaired. Sport is also an important social moment; playing matches in empty stadiums already causes undoubtedly a compression of these social moments. Completely banning them means going beyond compression, and perhaps poses a problem of a fair balance of interests at stake.
Then there are the economic and legal issues.
According to the “2019 Football Report”, published by the FIGC and produced by the Research and Legislation Agency (Arel) and the consultancy firm PricewaterhouseCoopers (PwC), in 2017-2018 the value of production of the three Italian professional championships (Serie A, Serie B and Lega Pro) exceeded 3.5 billion euros for the first time (of which 3 billion euros are attributable to the Serie A championship), an increase of 6% compared to the previous year.
According to the latest FIGC estimates, due to the coronavirus emergency, a loss of €424 million is already expected in 2020 (and €593 million in 2021), in addition to a further €294 million if it is decided to start playing behind closed doors again. The damage could be even greater if the season should be permanently suspended, for an estimated total of almost €800 million. This is certainly a huge damage for an industry that pays around 1.3 billion euros in tax and social security contributions and pays 2 billion euros in salaries to employees. The concrete risks are the bankruptcy of many companies (even 30% of C Series companies, according to unofficial estimates), a sharp drop in employment and a general disaffection of the public.
In addition to the economic damages mentioned above, failure to resume the league could also lead to severe sanctions by UEFA, which has clearly informed its 55 member football associations that, in the event of failure to resume the league at the end of the Coronavirus emergency, the clubs in those leagues will not be admitted to international Champions and Europa League competitions, as participation in the European cups is determined by the sporting results obtained at the end of an entire season.
In this context it must be considered what the closure of the stadiums and the definitive stop of the championship could mean from an economic point of view. Teams will have serious problems maintaining an adequate level of liquidity and will probably be forced to make cuts in players’ compensation (something that some Serie A teams have already started to do). The problems will be exacerbated if PayTv that have acquired the rights to broadcast the matches should face the impossibility of continuing their activities, in the light of a significant number of users who have signed subscription contracts for watching matches on demand.

Other European Championships
Some European championships have already been declared closed and in particular the Ligue 1 (France), Eredivisie (Netherlands), Jupiler Pro League (Belgium) and Scottish Premiership (Scotland).
As far as other nations are concerned, in Germany the Bundesliga resumed on 16 May, behind closed doors. The Deutsche Fußball Liga (DFL) set a maximum limit of 300 people inside the sports facilities and gave teams the opportunity to play a match in another stadium with short notice for legal, organisational and/or security reasons, taking into account that the Coronavirus emergency could take more relevant dimensions in certain areas or regions. In addition, DFL is also considering providing practical help to clubs by ensuring their liquidity.
The English Premiere League is considering restarting from June 12, again behind closed doors and on a neutral pitch, while training in small groups restarted on May 21. Stadiums away from urban areas will be chosen upon request of the police.
Training resumed on May 18th also for the Spanish Liga, but only in groups of 10, with the purpose to start playing again after June 20th. The days of the matches remain to be discussed (the proposal is to play every day of the week) and the times, considering the extremely high temperatures in the summer months, it is also proposed to play at 11pm in some areas.
Finally, in Portugal, the Primeira Liga will restart on May 30, with matches behind closed doors, players and arbiters will be tested the same day of the match. The Portuguese Serie B, however, will not start again.

Conclusions
Covid-19 is certainly a serious emergency, which can neither be minimized nor neglected. However, after an initial phase of understandable surprise and confusion, it now seems necessary to strive for a return to normality when the analysis of the available data, the resources available, and other interests involved suggest a thoughtful balance. Stopping everything clearly diminishes or eliminates contagions. But what is the economic, social, and psychological price? Is it truly impossible to find a system that allows activities to continue, obviously, with the acceptance of a certain level of risk? After all, this is what society normally does in relation to all risks associated with any activities, since none of them is free of risks. Driving a car carries a certain margin of accident risk, even fatal. Cars or driving have not been banned for this reason. Therefore, it is hoped that the same considerations will apply to the COVID-19 emergency and that there will be a restart of the Serie A Championship by June 2020, managed with the appropriate precautions, so that all players and staff members can resume their work, as calmly as possible, and respecting the prescriptions aimed at preventing further contagions.
Besides, as the renowned coach of the national team, Arrigo Sacchi, said, for many people football is the most important thing among the non-important things.

Margherita Stucchi


SEROLOGICAL TESTS AND PROCESSING OF PERSONAL DATA IN THE EMPLOYMENT CONTEXT: FURTHER CLARIFICATIONS BY THE ITALIAN DATA PROTECTION AUTHORITY

21/05/2020

With a press release issued on May 14, 2020 on its institutional site, the Italian Data Protection Authority (infra “Italian DPA”) published a new version of the FAQ (“Frequently Asked Questions”) [1], clarifying some unresolved aspects about the use of data from the so-called “serological tests” of employees. In particular, the Italian DPA denied the possibility for the employer to directly carry out serological tests to its employees without an explicit medical prescription and intended to regulate the processing of sensitive health data collected by private companies and public administrations.

 

Screening Tests System
The overall Covid-19 tracking and prevention system, in the light of the recent legislative initiatives aimed at a gradual resumption of production and professional activities, appears to be strongly conditioned by the use of sufficiently rapid and reliable monitoring methods, including screening tests (so-called “serological tests”). In this regard, as pointed out in the recent Circular no. 16106 published by the Ministry of Health on May 9, 2020, serological tests are an important aid in carrying out research and epidemiological evaluation of the viral circulation of Covid-19, as they allow to estimate the spread of an infection within the relevant community [2]. Obviously, these tests do not replace in any way the actual diagnostic tools such as the molecular test (so-called “Swab Test”), which remains (at least currently) the only method to ascertain the presence of the virus in the human body.

The Italian Data Protection Authority’s clarifications
In view of the growing diffusion of serological tests as a tool for “preventive screening” in the detection of infection and in order to clarify the proper implementation of the “Shared Protocol for the regulation of measures to combat and contain the spread of the Covid-19 virus in the employment context”[3], the Italian DPA recently published concrete rules to define the scope of intervention and the responsibility of the employer in the processing and disclosure of personal data. First of all, as regards the scope of prevention measures and safety protocols in the employment context, it is impossible for the employer to carry out a serological test on his employee. “Only the appointed doctor – points out the Italian DPA – “in the context of health surveillance, can prescribe clinical and biological examinations, as well as the competent doctor can suggest the adoption of diagnostic tools, when he considers them useful for the containment of the spread of the virus and the health of workers”[4]. Consequently, only in case of specific utility and after obtaining the consent of a health professional authority will it be possible to require the employee to undergo diagnostic tests. From another point of view, it is clarified that nothing prevents an individual employer from offering its employees, bearing all or part of the related costs, the possibility of carrying out serological tests in public and/or private facilities, without however being able in any way to know the final result of the test.
COVID-19 serological screenings may be promoted by the Preventive Medicine Departments of each Region with regard to the categories considered to be at greater risk of contagion and spread of COVID-19. These include health care professionals and law enforcement agencies and the participation of these entities in the tests can only take place on a voluntary basis. The results may be used by the healthcare facility that has carried out the test for the purpose of diagnosis and to provide for the epidemiological containment measures.

Processing of Personal Data
The Italian DPA has also expressed its opinion on the conservation and treatment of information relating to the diagnosis of the employee. This information cannot be directly processed by the employer, who is not authorised to consult the reports and the specific results of the examinations carried out by his employee, except in cases expressly permitted by law. On the contrary, the official FAQs clarify that “the employer must process data concerning the worker’s judgement of suitability for the job and any prescriptions or limitations that the appointed doctor may establish”. Moreover, in order to be able to readmit the employee to work on a regular basis, the examinations and any checks deemed necessary must be carried out exclusively by the appointed doctor or other health authorities, in full compliance with the general provisions that strictly forbid the employer to carry out any kind of direct diagnostic examinations on the employees.

Conclusions:
These latest guidelines issued by the Italian Data Protection Authority come in addition to the numerous clarifications published in the last few weeks, with regard to the processing of personal data in the employment context. These include the absolute prohibition for the employer to disclose the identity of an employee affected by Covid-19. Since this health data is sensitive and confidential, the employer is required to provide the competent institutions and health authorities with the necessary information, so that they can inform the “close contacts” of the diseased employee in order to implement the required prevention measures. “Data concerning health may only be disclosed”, specifies the Italian DPA, “whether externally or within the organization an employee or collaborator pertains to, if this is provided for in the law or ordered by the competent authorities on the basis of statutory powers”.
Finally, it should be noted that, despite the clarifications made by the Italian DPA, there are still some critical aspects in relation to the effective communication and knowledge of sensitive health data within the company’s structure and to the person of the employer. Specifically, in the event that a person chooses to undergo a screening test privately and independently to ascertain its condition and results positive, this result will be reported to the competent Health Protection Agency, which will provide targeted emergency measures and the consequent obligation for the person concerned to undergo a diagnostic swab to confirm the actual presence of the virus. In this case, the specific medical data involved will be communicated to the employer, who will become aware of it through the competent doctor and will therefore have this confidential information concerning his employee. In light of this, it is clear that some aspects relating to the disclosure and processing of personal data in the employment context do not emerge with sufficient clarity from the recent integration published by the Italian DPA and do not fully comply with the reality, merely providing general and not exhaustive guidelines. It is therefore desirable to consider a new clarifying intervention to ensure the right balance between the health needs dictated by the emergency situation and the need to preserve the individual’s right to privacy.

[1] Full version document is available at the following institutional site: www.garanteprivacy.it
[2] The Ministry of Health, with the circular dated 29 April 2020, stated that “serological tests, according to WHO indications, cannot replace the molecular diagnostic test on swab, however they can provide epidemiological data regarding the viral circulation in the population, including the working population”.
[3] As published in its original version on March 14, 2020 and later amended on April 24, 2020.
[4] For further details see par. 12 of the Protocol shared between the Government and the Social Parties updated on 24 April 2020.

Paolo Rovera