COVID-19 AND PATENT PROTECTION: A CALL FROM THE WHO TO CREATE A TECHNICAL POOL REGARDING VACCINES AND CURES

09/06/2020

Last month the World Health Organization welcomed the initiative presented by Costa-Rican functionaries to create a platform of solidarity for sharing the patenting rights anti-Covid-19. The topic raises many questions, considering the monopolistic nature of intellectual property rights and various interests involved. Among them, the right to health and to economic initiative.

 

World Health Organization’s recent initiative
Last May 18th 2020, the World Health Organization welcomed the initiative to create a “Covid-19 – Intellectual Property Pool”. The plan, presented weeks ago by Costa-Rican functionaries, proposes to create a platform of solidarity for sharing the patenting rights, data from tests and other information necessary for the development of drugs, vaccines and diagnosis tests for COVID-19.
The initiative was born from the concern that, in a near future, anti-COVID19 medical products could possibly not be accessible to the world’s poorest populations. According to the initiative, the creation of a platform of voluntary solidarity under the WHO would allow the creation of a path shared among governments, companies, universities and no-profit organizations – the decision-making body of the WHO – is evaluating the adoption of the resolution presented by the European Union. The resolution incorporates Costa Rica’s proposal and aims at ensuring that less developed countries will have access to the use of products claimed by any patent applications for drugs or medical products against Covid-19.
The topic is sensitive, considering the monopolistic nature of intellectual property rights; furthermore, it would require a specific intervention which, despite the exceptional situation created by Covid-19, still respect the general principles of the judicial system and properly regulates any potential economic fallout. The interests at stake are numerous: firstly, there are countries’ national interests, as the COVID-19 vaccine may be used as a competitive advantage at a geopolitical level. Secondly, the intellectual property rights of pharmaceutical companies must be considered, indeed economic returns on any investments made should be guaranteed (in the context of COVID-19 we have seen a unique mobilization of human and financial resources in the history of medical research). Lastly, as a primary assert, public health should be protected since it is a fundamental right recognized by all constitutional charters.

Knowledge sharing or mandatory licensing of patents?
It is necessary to distinguish between two possible methods of international cooperation in the fight against COVID-19. Countries could collaborate in developing and producing new drugs, diagnosis methods and vaccines, also including the cooperation of public institutions such as universities or research centers. In this case, an agreement could be reached, also utilizing the aforementioned “call” made by WHO, with the aim to guarantee equal access to any medical product resulting from the shared research. Alternatively, the private property rights and their negotiating circulation could be regulated in such a way as to guarantee their use to the largest number of people possible. Here the choice could be varied: either, as the WHO suggests, a suspension of the legal monopoly rights on inventions specifically intended for the care and treatment of COVID-19 (moreover it would then be necessary to distinguish with respect to the etiology of symptoms that the COVID-19 has in common with other pathologies), or the remodeling and compression of these rights.
The approach of the voluntary sharing platform differs, in fact, from the proposal – coming from non-governmental organizations and academic experts – instead aiming at urging States to resort to the institution of compulsory licenses. The latter is an instrument of flexibility introduced by the agreement of the World Trade Organization: “Trade-Related Aspects of Intellectual Property Rights” (hereinafter, TRIPS). The compulsory licenses allow for either the production of patented drugs, in the presence of certain circumstances, or the import of these from another country in case the importing country lacks the pharmaceutic-industrial infrastructure necessary (parallel imports), without the patent holder’s consent. The route which allows to activate the compulsory licenses is composed by a series of progressive phases.
Firstly, a national health emergency must be occurring so that a formal request may be made to the rights holder for an immediate authorization for the production of the necessary drugs. If the rights holder were to not grant their consent, then it is possible to proceed to an imposition of a compulsory license (granted that a severe health crisis is underway in the petitioning country) and this in the face of the willingness to pay a reasonable fee to the holder of the patent itself and on condition that the compulsory license is limited temporally and geographically.
In the past few years, several developing countries have resorted to the compulsory license instrument due to the high cost of drugs, facing hard battles with the pharmaceutical industry. Two litigations should therefore be recalled: one in South Africa (cfr. South African Pharmaceutical Manufacturers Association v. The Government of South Africa, Case No. 4183, 1998, High Court of Pretoria) and the other in India (cfr. Novartis AG v. Union of India (UOI) and Ors.; Natco Pharma Ltd. v. Uol & Ors.; M/S Cancer Patients Aid Association v. Uol & Ors) which have involved two big pharma. These last two had accused the mentioned States of having implemented and interpreted the clauses of intellectual property limitations present in the TRIPS in a manner which was too extensive, therefore violating the relative constitutional principles of economic liberties. In the two examined disputes, the national judges highlighted the social and other fundamental rights, like the one to life, health and human dignity, legitimizing the economic policies of the countries cited of application of the clauses of limitation of the intellectual property stipulated by the TRIPS.

Western countries failure to join (so far) the sharing platform
The formal launch of the sharing platform and with it the suspension of industrial property rights for pharmaceutical and medical anti-COVID-19 products had been planned for the 29th May 2020. According to what so far communicated by the WHO, the first countries to join the initiative were Argentina, Bangladesh, Barbados, Belize, Brazil, Bhutan, Chile, Dominican Republic, Ecuador, Egypt, El Salvador, Honduras, Indonesia, Lebanon, Luxembourg, Malesia, Maldives, Mexico, Mongolia, Mozambique, Norway, Oman, Pakistan, Palau, Panama, Peru, Portugal, Saint Vincent and Grenadines, Sri Lanka, South Africa, Sudan, Netherlands, Timor Est, Uruguay and Zimbabwe. Still missing are western countries (the majority of EU members and the USA), together with Israel, China, Japan and India, all countries were the world’s big pharma are headquartered. The current list includes, therefore, many developing countries that do not have particularly developed technological, producing and distributing capabilities.

The measures adopted by individual countries against the monopoly of the Covid-19 vaccine
In pandemic’s current context, the compulsory license instrument, however, has not attracted only developing countries. States like Germany, Israel, Ecuador, Brazil and Chile are moving towards compulsory licenses for patents related to the handling of COVID-19, while the United Kingdom and Canada have both stipulated the decriminalization of the exploitation of patents related to COVID-19. The decriminalization would entail the exclusion of counterfeiting crimes regarding COVID-19 patents.
The compulsory license, instead, would have the goal of ensuring equal access to drugs relating to the cure of the pandemic. Other legal systems, including the Italian one, allow the state to rapidly seize any patent due to public need, for an indemnity to be paid to the owner of the industrial property right. This is a real expropriation procedure, through which a so-called “forced” solidarity of the patent’s owner would be secured, thus eliminating the legal monopoly in which this is expressed. It is believed, however, that in taking into account the current situation, pharmaceutical companies would be interested in spontaneously releasing for free or in any case in a “social-friendly way” any exclusive rights on drugs or vaccines anti-COVID-19, thanks to the immense return in image that such an operation would guarantee.

The expropriation procedure of the patent for national utility in Italy
As far as Italy is concerned, art.141 of the code for industrial property (hereinafter, “c.p.i.”) stipulates that industrial property rights, trademark rights excluded, although in progress of registration and patenting, can be expropriated by the State in the interest of the State’s military defense or for other reasons of public need. The State can expropriate the right as a whole or even just the right to use the invention in the national interest and for a specific period. Second paragraph of art. 141 c.p.i. continues by stating that the expropriation can be limited to the right of use for the State needs, without prejudice to the provisions on compulsory licenses, insofar as they are compatible.
National legislation does not regulate in detail the expropriation of industrial property rights, nor has the subject been the focus of case law. In any case, it is clear – from the dictates of art. 141 c.p.i. – that the expropriation of the industrial property right is subject to certain conditions.
First, the expropriation is adopted with a Presidential Decree at the end of a complex legislative procedure. In particular, the expropriation is issued through a Decree of the President of the Republic, following a proposal of the concerning Minister, in concert with the Ministries of Productive Activities, Economy and Finance, after hearing the opinion of the Appeals Commission. Art. 194 c.p.i. provides that the decree should be sent in copy to the Italian patent and trademark Office and then published in the Official Bulletin unless this creates a prejudice. Furthermore, the decree must be notified to other interested parties. Once all the above notifications have been made, the right object to the expropriation is acquired by the Public Administration, which will be able to use it within the time limits and for the duration envisaged. Finally, according to art. 143 c.p.i. the decree must be annotated in the Register of industrial property rights. Contrary to what happens if the expropriation due to military defense reasons, the secret of the object of the industrial property title is not stipulated for reasons of public need.
The Presidential Decree must specify an indemnity in favor of the industrial property rights holder. Such indemnity is calculated based on the market value, after hearing the opinion of the Appeals Commission. However, the legislation does not provide concrete parameters that should be used to estimate the indemnity. In case of non-agreement – art. 143 c.p.i., indeed, provides that the owner of the industrial property right may disagree with respect to the value of the indemnity established by the Decree – the indemnity must be fixed by a panel of arbitrators who will proceed according to fair appreciation, taking into account also the loss of competitive advantage suffered by the owner of the expropriated right.
As mentioned, the expropriation measure, which eliminates or limits the industrial property right, can be adopted only if there are reasons of public need (as well as in the interest of the country’s military defense).
Therefore, it is necessary to understand if needs of this type could arise in the pandemic’s current emergency situation. The question is only apparently superfluous, as, until today, no health emergency and no disease (even cardiovascular or tumour diseases that nonetheless in numerical terms have an impact far superior to all other diseases) has never been recognized as a reason of public need, such as to justify a State intervention for the regulation of patent protection (suspension) or to induce to force the “solidarity” of private entities. In a broad sense, any resources aimed at safeguarding and preserving human life and health could fall within the concept of “public need” almost by definition. At present, it cannot be foreseen whether the WHO’s declaration of pandemic status is such as to justify the possible expropriation of patents concerning COVID-19 drugs or vaccines.
As there is no case law on the subject, the national courts, if requested, will have to resolve the issue through a balanced weighing of the interests at stake, which in this case are private property and economic initiative (art. 41 of the Constitution) and law to substantial equality and health (articles 3 and 32 of the Constitution).
It is interesting to note how an evaluation of this type has already been the subject of a decision made by Lazio’s TAR, in a case that concerned not the expropriation of the industrial property right on drugs, but the duration of the complementary certificates (cfr. TAR Lazio, sez. III del 30/09/2003, n. 7858, in Banca dati online De Jure). In that instance, TAR stated that art. 41 Cost. “is not, however, an absolute right of the personality that therefore overlooks the limits that the Constitution itself, also thanks to the implementation that the ordinary legislator gives from time to time and within the obvious limits of the reasonableness and substantial equality of citizens, imposes for social needs. In principle, economic efficiency, connected to the stability of relationships and legal traffics (especially for long-term ones) is indeed a protected value, but not hierarchically prevalent compared to other social needs. Indeed, the discipline of the economy, which the Constitution wants dictated by the ordinary legislator, must not only be inspired by the intent to pursue immediately economic purposes (increase in production, financial balance, etc.), but also guided by the need to stimulate and favour the process of social transformation, the main lines of which are traced by art. 3, II para”.
In the case cited, the Italian judges recognized the economic initiative as a value protected by the law, considering it, however, hierarchically not prevalent with respect to the principle of substantial equality provided for in art. 3 Const.
Applying this perspective to the current pandemic situation, with a view to ensuring the full implementation of the principle of substantial equality, the right to ensure access to the COVID-19 vaccine for all citizens could be considered a right superior to that of ensuring compensation and the fair return on investment to the vaccine-producing pharmaceutical industry.

Conclusions
In this situation, whether the choices are made at a supranational level (as for the WHO initiative to define a real suspension of rights arising from patents or in any case to define a technical pool that indicates similar solutions in view of the protection of less fortunate sections of the world population), or that they are taken at national level through the initiation of expropriation measures or the granting of compulsory licenses, it will still be necessary to consider carefully, not only on a juridical level, the future implications of eventual initiatives. Indeed, it will be appropriate to seek and find a balance between the protection of investments made by pharmaceutical companies – but also by private or public institutions – and the pursuit of the aim in question, that is facilitated access to the cures and vaccines. This is also to ensure that pharmaceutical companies continue to invest in research and development, especially in the current pandemic context, and that this type of research can still continue to positively attract private capital. It must be said that a just solidarity initiative in the current situation must not however set a precedent for questioning the need for patent protection of pharmaceutical or medical inventions. The pandemic indeed constitutes a completely atypical situation, not comparable to any other and is a situation such as to justify the introduction of a very special exception, that would then not be able to render ineffective or cancel out (rather, reaffirm) a principle of great importance for technical, economic and social development of each country, the principle of patent protection granted to pharmaceutical and medical inventions.

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


RIGHTS HOLDERS, ISPS AND USERS’ DATA BETWEEN COPYRIGHT AND GDPR: WHILE AWAITING THE DECISION ON THE CONSTANTIN CASE, THE DUTCH JUDGE HAS RULED

19/05/2020

The Hague District Court, by decision published on May 6, 2020, ordered a well-known Dutch service provider to provide the rights holder with users’ data, including e-mail addresses, claiming the compliance of this order with the General Data Protection Regulation no. 2016/679 (commonly known as GDPR).

 

The facts underlying the dispute
The action was initiated by Dish Network, a US pay-TV provider, which holds the exclusive rights for the broadcasting and public exhibition in the United States of copyright-protected television programmes through means including satellite, OTT, IPTV and the Internet. The rights holder discovered that two IPTV were transmitting its own content without permission, through IP addresses owned by the provider WorldStream, which provides hosting services.
The rights holder sent the provider a series of cease and desist letters requesting the disabling of access to IP addresses linked to the illicit IPTV. WordStream provided the blocking as requested.
However, the dispute arose when the rights holder requested the provider to disclose information that would have enabled the identification of the users connected to the blocked IP addresses. In this regard, WorldStream stated that it could provide such information only upon a full discharge for any liability under GDPR granted by Dish Network. Not satisfied with WordStream’s proposal, Dish Network therefore sued this provider to be ordered to release the following information:
(A) Name and address of the users, including their e-mail address and, in the case of legal entities, their registration number in the business register of their home State;
(B) users’ phone numbers, date of birth and WorldStream user ID and, in the case of legal entities, all this information for their legal representative; and
(C) payment information, users’ traffic data, correspondence with WorldServe, other user IP addresses, as well as a range of additional information.

The decision of the District Court
The request of Dish Network was based on a general provision to access evidences, Article 843a of the Dutch Code of Civil Procedure – DCCP, in combination with Article 1019a DCCP, which implements Article 6 of the Enforcement Directive, according to which any person has the right to request evidence from his counterparty if he has a legitimate interest in obtaining it. The request concerns specifically identified evidences that are in the possession of the other party and relate to a legal relationship to which the claimant is a party.
The District Court found that, in the present case, Dish Network had a legitimate interest in obtaining the information and that it sufficiently demonstrated that its intellectual property rights were actually infringed by WorldStream’s customers to ensure its disclosure.
However, the District Court limited disclosure only to names, addresses, e-mail addresses and, in the case of legal persons, registration numbers (point A of Dish Network requests), while it rejected the request for disclosure of further information such as telephone numbers, dates of birth, payment information and other data. According to the Court, those additional data had not been sufficiently identified and, in any event, in application of the proportionality test, the information relating to names, addresses and e-mail addresses had been deemed sufficient to identify the users who had committed the infringement of the applicant’s rights. In view of the limited scope of the order, the District Court also found that WorldStream’s compliance did not constitute an excessive burden.
In relation to the question of the admissibility of the disclosure order under GDPR, the District Court stated that Article 6(1)(f) of GDPR allows the processing of personal data where this is “necessary for the purposes of the legitimate interests pursued … by a third party”. In the present case, the processing of personal data was considered necessary because Dish Network would have had no other means of tracing users and asserting its rights, thus considering the applicant’s interest in protecting its copyright prevailing over users’ privacy rights.

This decision is of particular interest because it is closely related to the case currently pending before the Court of Justice of the European Union (CJEU) in case C-264/19 Constantin Film Verleih [https://www.lexology.com/library/detail.aspx?g=5f7486e7-e73e-4cdc-81af-0a0e65de8cbe]. In the judgment before the CJEU, according to the Opinion of 2 April 2020 of Advocate General Saugmandsgaard Øe, the order of disclosure of data must not include e-mail addresses or telephone numbers, as the terms “names and addresses” in Article 8(2)(a) of the Enforcement Directive should be interpreted very narrowly. The decision of The Hague District Court, however, was based not only on the interpretation of Article 8 of the Directive but, as has been seen, on general national rules on access to evidence, which give the right holder the power to receive more complete information. This, moreover, in full compliance with the Enforcement Directive, which leaves open the possibility for Member States to provide rightholders with means of collecting more extensive information.
However, it is interesting to highlight the balance of rights made by the District Court, which considered necessary the access to data by the owner of the rights for a full protection of the same rights, that prevail over the right to privacy of users (only applicable to users who are natural persons and not also to legal persons, for whom it is not possible to speak about personal data).
The Dutch decision is similar in some aspects to the Milan and Roman decisions issued in 2019 [https://www.lexology.com/library/detail.aspx?g=5f7486e7-e73e-4cdc-81af-0a0e65de8cbe], which however appear – correctly – to be even more far-reaching. The decisions at issue have ordered some hosting providers to provide the rights holder with all the information relating to users and useful for their identification, such as name, surname, date of birth, place of birth and address, tax code, or name and registered office and identification number for tax purposes or registration in the business register, or similar, in the case of a legal person. This is allowed pursuant to articles 156bis and 156ter of Law no. 633/1941, which expressly provide for the right holder to request a discovery order for the counterfeiters’ data. Moreover, it should be noted that in many cases some of the data used by counterfeiters when using the hosting services are false and completely unsuitable for the actual identification of the counterfeiters themselves (such as name, surname, email address). Frequently, payment data are also of little use, since counterfeiters use anonymisation services. Consequently, it seems only fair that the infringing right holders should be able to access all the information available to the provider, and that the provider should provide maximum cooperation for identification, and that in the absence of such good faith behaviour an independent and direct liability can be incurred.

Margherita Stucchi


ITALIAN SUPREME COURT NO. 8433/2020: CONFIRMED THE COPYRIGHT PROTECTION FOR KIKO’S CONCEPT STORES

13/05/2020

The Italian Supreme Court has confirmed that a project or work of interior design con be considered as a work of architecture if a series of characteristics are met, i.e. a unitary design, a clearly defined and visually perceptible pattern, a clear stylistic key and the personal imprint of the author.

 

The decision puts an end to the dispute between two well-known companies active in the production of cosmetics, namely KIKO and WYCON: KIKO had taken legal action against the competitor, complaining that WYCON had unduly taken over the aspects of its concept stores designed by an architecture firm on its commission, thus violating its copyright on the project. Moreover, KIKO claimed rights under the law of unfair competition, because of the identical takeover of other elements, such as the vendor’s clothing and accessories, the website’s format, the commercial promotions and the products developed.

With decision no. 11416/2015, the Court of Milan had already recognized the creative and original character of the design of the plaintiff’s stores, highlighting that the choice, the combination and conformation of the furnishing elements used by the plaintiff presented sufficient elements of creativity, since they were not imposed by the technical problem that the author wanted to solve, such as to make the architectural project original and creative. The damage suffered by KIKO was quantified in Euro 700,000.00. The liquidation considered the amount paid by KIKO for the realization of the project, multiplied by 10. After confirmation at the appeal, WYCON appealed to the Supreme Court, motivated inter alia by the incorrect quantification of the damages suffered by KIKO.

With decision no. 8433 of April 30, 2020, the Supreme Court focused on the objection raised by the appellant that a the interior of a concept store could not be protected as a work of architecture, within the meaning of Article 2(5) of the Italian Copyright Law, because it lacked the identification of a specific building area, in which the work should be incorporated, and the organisation of that area by means of fixed structural elements.

The Court, considering the argument unfounded, pointed out that an intellectual work is protected by the law on condition that it contains an original element or combination result of creativity, in order that it may be identified, even though it is part of a common genre, to be a singular product of the author and to be identified among others similar. The notion of architecture would therefore include an activity which is “aimed at the creation and modification of spaces to make them usable by man”, therefore also comprising the organization of interiors.
On the basis of these assumptions, the Court stated that “on the matter of copyright, a project or work of interior design, in which there is a unified design, in a visually perceptible pattern, which reveals a clear “stylistic key”, of individual components organized and coordinated to make the environment functional and harmonious, or the personal imprint of the author, can be protected as a work of architecture, pursuant to art. 2 no. 5 Italian Copyright Law, regardless of the requirement of an inseparable incorporation of the furnishing elements with the building, which is not present in the above provision, or the fact that the individual furnishing elements constituting it are or not simple or common and already used in the sector, provided that it is an original combination result, not imposed by a technical-functional problem that the author wants to solve”.
As regards the liquidation of the damage, the Court has annulled the decision and has referred the case back to the Court of Appeal for a new quantification of the damage suffered. According to the Court, the quantification of the damage made by the Court and the Court of Appeal was arbitrary.
This decision is of particular importance not only for architectural and interior design firms, but also for all entrepreneurs who invest their resources in the creation of an environment within their stores, offering their clients the moment of shopping itself as a 360-degree experience for which the interior decoration of their stores is of crucial importance.

Paolo Passadori