Top 3 predictions for life sciences in 2019

The Life Sciences industry operates in one of the fastest and most innovation-driven environments. 2018 has witnessed significant developments in technology and therapeutic practices. A number of new cell and gene therapies – including the first two CAR-T therapies for cancer – received EU approval, and both disruptive and ‘new mainstream’ technologies (such as AI) made significant steps forward into the sector.

The pharmaceutical and medical device sectors are also among the most heavily regulated. Life Sciences companies face significant challenges in managing regulatory compliance in an environment where regulation constantly evolves. Moreover, the sector moves so fast that it is hard for regulation to keep up with the pace of technological development.

Top 3 predictions on new tobacco products and e-cigs

Since their first placing on the market, electronic cigarettes – better known as “e-cigs” – and novel tobacco products (“NTPs“) have been a controversial topic of discussion.

Due to the proximity of e-cigs and NTPs with traditional smoking products, lawmakers have had to deal with great issues involving not only authorization requirements and procedures but also issues concerning boundaries in advertisement, taxation and how to address problems such as underage smoking.

Directive 2014/40/EU sets out the general legal framework for NTPs, e-cigs and e-liquids (nicotine and nicotine-free liquids meant to be vaped) in the European Union. In Italy, the latter has been implemented by means of Legislative Decree 6/2016, which has already seen a number of amendments in roughly three years of life.

Top 3 predictions on AI and IoT for 2019

There was massive growth of Artificial Intelligence (AI) in 2018, which followed the hype of Internet of Things (IoT) technologies during the previous years. But what is going to happen in 2019?

Here are our top 3 predictions for the year.

Top 3 predictions on fintech for 2019

Thanks to the implementation of the PSD2, we can say that 2018 has been the year of fintech in Europe, with new players finally hitting the market or old players proposing new services.

What to expect for 2019 then? Below our podium predictions on fintech for 2019.

Top 3 predictions for trade secrets in 2019

by Laura Gastaldi, Fulvia Cosattini, Micaela Jerusalmi Striking the balance between opposite demands In order to harmonize the different legislations adopted by each EU Member State and strengthen the protection of know-how and trade secrets, on the June 8, 2016, the EU Parliament and the Council of the EU enacted EU Directive No. 943/2016 (“the …

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Top 3 privacy predictions for 2019

2018 brought us considerable changes in the data protection world. The EU General Data Protection Regulation No. 679/2016 (GDPR) finally became applicable, introducing in the privacy law context its expected innovative principles and rules. But as soon as the GDPR entered into force, the EU Member States began to think about the adequacy of their national legislation. As a consequence, most of EU countries decided to adopt a new local legislation in order to review, amend and, therefore, adequate their local laws to the newcomer GDPR.

But what will happen in the next 12 months? Here our personal predictions on privacy legal issues for 2019.

Top 3 predictions for patent litigation in Italy and EU

The long story of the EU patent, commenced in 1975 (!) with the aborted Community Patent Treaty, which ultimately led to the Unitary Patent (established by Regulation (EU) No 1257/2012) and to the Unified Patent Court Agreement, done at Brussels on February 19, 2013 but not yet entered into force, will eventually come to a conclusion in 2019.

This very year will indeed clarify if and how Brexit will take place and affect the UP/UPC package and its entry into force, as well as the possible role of the UK in said system.

In parallel, the German constitutional court is expected to decide on the claim brought against the system and its compatibility with the German and EU laws; such a decision could easily mean a final “yes” or “no” to the system, the “no-side” including also the possibility that the case is referred to the EU Court of Justice.

Top 3 gambling law predictions for 2019

It was a very busy year for the gambling sector with operators and suppliers that might be forced to reinvent, or at least considerably adjust, their business model to suit new markets, following their opening up, and new market conditions, due to recent regulatory restrictions.

Below are our top 3 predictions for 2019.

Top 3 Predictions for copyright in 2019

Copyright law is an evolving force. Indeed, its pivotal feature is human creativity – something hard for mankind to get rid of. So, what will happen in 2019 in copyright law in Italy and elsewhere? What are the main trends in copyright law for the next year?

Top 3 predictions for eSports in 2019

The eSports industry is in a period of rapid growth, but the growth of a market often leads to legal issues and obstacles that need to be overcome in order to achieve its potentials.

There is at the moment a range of legal and business issues where eSports need a more comprehensive approach involving learnt lessons from the sports and the gambling sectors.

Below are our top 3 predictions on the legal issues that will affect the eSports industry in 2019.

The fight against counterfeiting continues: the first Counterfeit and Piracy Watch List is now out.

After the public consultation launched last January, on 7 December 2018, the European Commission (EC) published the first Counterfeit and Piracy Watch List, which provides examples of reported marketplaces or service providers located outside the EU and engaged in counterfeiting and piracy.

Such Watch List was highly expected by right holders and represents the last measure adopted by the EC against infringers, after the Overview of the functioning of the Memorandum of Understanding on the sale of counterfeit goods via the internet (MoU) in 2016 and the Guidelines for online platforms to tackle illegal content in 2017.

Loot boxes reviewed by the US Federal Trade Commission and in Australia

The Australian Senate Environment and Communications References Committee advised the Australian Government to undertake a comprehensive review of loot boxes within video games. The report published by Australian Authorities noted that loot boxes are “not a homogeneous entity” and there are many different iterations of the mechanic.However, a range of stakeholders, including regulatory agencies and academics, referred to the committee that loot boxes should be assessed on a case-by-case basis. In this respect, it should be considered that there are a number of types of loot boxes available in video games.