Some hard numbers reveal the paradox: the EU has a highly developed research sector vs. the EU is a region with a challenging commercialization environment compared to other global leaders.

Biotechnology is one of the fastest-growing research and innovation sectors in the world today, and the European Union plays a significant role in this process. Over the past decade, the number of biotechnology researchers in the EU has nearly doubled, from approximately 42,000 in 2012 to over 81,000 in 2021, and the share of employment in this field has reached 17.2% of total R&D employment. These figures confirm that Europe has a strong scientific base and is systematically building capacity in technologies critical to health, industry, and food security.

However, when we look at what happens next – patents, technology scaling, and market penetration – the picture becomes less optimistic. The EU’s share of global biotech patents fell from 22.6% in 2001 to 18.3% in 2020, while the US still accounts for nearly 40% of global patent filings. On a per capita basis, the difference is even more pronounced: in 2020, the US had three times the number of biotech patents per million inhabitants than the EU.

However, it is worth breaking down this general picture into its first factors, because biotechnology is not a single sector, but a collection of very different areas that operate in different market and regulatory conditions.

Red biotechnology:

Red biotechnology, encompassing medical and pharmaceutical applications, is the largest and most capital-intensive segment of the entire sector. It is here that a significant portion of biotechnology patents worldwide are created. Between 2001 and 2020, medical-related technologies, including peptide preparations and antibody-based solutions, accounted for a significant portion of all patent applications in biotechnology.

Europe is scientifically strong in this area. Universities, research institutes, and clinical infrastructure are among the world’s leading. The problem arises at the commercialization stage. Drug development requires enormous financial resources, a long time frame, and a stable, predictable regulatory environment. Meanwhile, in the EU, these processes are often perceived as more complex and dispersed than in the US. As a result, many technologies developed in European laboratories reach the market under the auspices of American companies – through acquisitions, licensing, or transferring further stages of development outside of Europe.

White biotechnology:

White biotechnology, or industrial applications, is the largest category of biotechnology patents worldwide. Technologies such as processes based on microorganisms, enzymes, and biochemical tests collectively account for over one-third of all biotechnology patents filed between 2001 and 2020.

This is an area of particular importance from the perspective of industrial transformation and the green economy. Interestingly, it is in white biotechnology that Europe, alongside Japan and China, demonstrates relatively higher specialization than the United States. Despite this, the EU’s share of the global patent portfolio is not growing. Why? Scaling is again crucial. Industrial technologies require a rapid transition from pilot to large-scale production, which in turn depends on access to capital, infrastructure, and a single market. Regulatory fragmentation and national differences mean that European companies often develop more slowly than their competitors.

Green biotechnology

Green biotechnology, primarily related to agriculture and food security, accounts for the smallest portion of the patent portfolio – the number of applications in this area is relatively low both in the EU and globally. Despite this, the importance of this segment is growing.

Globally, China demonstrates a clear specialization in green biotechnology, while in the EU, only a few countries, such as the Netherlands, have a clear competitive advantage in this area. This demonstrates that the potential exists, but is not being utilized evenly. Mechanisms are lacking to develop these technologies across the EU and make them a real pillar of innovation.

Horizontal biotechnologies

Horizontal biotechnologies, which can be applied across multiple sectors simultaneously, account for a small percentage of patents (around 2%). However, their importance is greater than their scale suggests. These are often technologies that can accelerate innovation in other areas. The example of Great Britain demonstrates that even with a relatively small number of patents, high specialization can be achieved, although in this case we are also talking about a niche, not a mass market.

Analysis of individual areas of biotechnology leads to a common conclusion: regardless of the sector, the European Union is consistently building research and technological potential, but significantly underutilizes it during the growth and commercialization phases. In red biotechnology, barriers include long and costly market development paths; in white biotechnology, barriers include limited ability to rapidly scale industrial processes; in green biotechnology, barriers include low innovation rates and strong differences between Member States; and in horizontal biotechnologies, barriers include small scale despite high technological significance.

As a result, biotechnology in the European Union accounts for a patent portfolio close to the global average, while in other leading regions it accounts for a significantly larger share of total patent activity. At the same time, patent activity in the EU remains highly concentrated geographically in a few Member States, primarily Germany and France. This means that the potential of the single market as a development space is not being fully exploited.

In this context, the Biotech Act addresses the clearly defined gap between potential and utilization. It does this by introducing uniform definitions and procedures, reducing the need to navigate separate national systems. This eliminates the need for projects to undergo separate, uncoordinated administrative processes, and the time required to obtain key approvals is shortened. At the same time, the act facilitates access to financing and regulatory support, especially for SMEs, reducing the risks and costs of market entry. The Biotech Act aims to foster better links between the European research base and the market, strengthen commercialisation capacity and enable companies to develop within the single market rather than seeking more favourable conditions outside Europe.

All data used in this document come from: Grassano, N., Napolitano, L., M’barek, R., Rodriguez Cerezo, E., Lasarte Lopez, J., Exploring the global landscape of biotech innovation: preliminary insights from patent analysis, Joint Research Centre, European Commission , Luxembourg , Publications Office of the European Union, 2024.

Artykuł Biotech Act – why and for what purpose? pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Biotechnologia.pl, which is the main polish media in biotechnology sector, recommends KG Legal’s article on its homepage.

Patent has its limitations, which are given in article 69 of the Polish Industrial Property Law. In our article we focused on two of them: research exemption and Bolar exemption, which are provided respectively in article 69 paragraph 1.3 “applying an invention in activities related to research and experiment for the purposes of analysis and teaching” and paragraph 1.4 “exploiting an invention to the extent necessary with a view to perform actions which are legally required to obtain an entry into a register or a licence, being a precondition for admitting certain products into trade given their purpose, in particular medicinal products”.

The article was prepared by our law firm and it discussess patent and patent exemptions, differences between research exemption and Bolar exemption, the relationship between commercialization of research and research exemption, as well as two ways of carrying out research on the basis of the research exemptions.

Artykuł KG Legal’s article is recommended by the main polish biotechnological media pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

See the link to the article in Polish: http://mojafirma.infor.pl/prawo-autorskie/patent/749659,2,Polskie-startupy-w-IT-i-biotechnologii-ochrona-prawna.html

The information was prepared by Kamil Trzaskoś of KG Legal Polish Law Firm. KG Legal provides specialised legal assistance to IT, Life Science as well as investment processes in Poland and organises networking between Polish and international companies and research centres.

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Artykuł Polish start-ups in new technologies and biotechnology and relevant Polish law pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Operation of the Garage LifeScience

In the second part of the programme, dr. Piotr Warchoł (also co-founder of Complexity Garage) introduced operation of the Garage. There are three categories of membership:

– regular

– academic

– commercial

The regular membership will gather mostly people unrelated with univerisites, but related with the DIY culture, that would create Open Space projects. To use the Garage they will have to pay a small fee.

The academic membership is free and is designed for scientific circles, researchers, which, from various reasons will not be able to carry out research at the University and also for students participating in competitions.

The last type of membership – commercial is directed to companies, that do not need or cannot afford laboratory for full-time. So it will be, mostly, microenterprises and start-ups. The fee will be proportional to time spent in Garage.

Cooperation between companies and Garage of LifeScience

There is also a possibility to establish a commercial partnership, that is intended for larger companies and organisations, which would have internships, workshops, trainings or projects, that, from various reasons, do not want to carry out in their laboratories. Financial conditions will depend on individual arrangements.

New and modern Laboratory in Cracow

Space laboratory is taken care by lab tutor, which is responsible also for contact with press. To get to the laboratory you must have an access card. If you are working on a project, you will have to go to reception each time and get an access card. The laboratory is equipped with fume hood, ultrasonic washer, vortex and many other devices. In case of need to use devices, that are not in Garage, there is a possibility to use apparatus of one of Garage’s partners.

How to get, with your project, into Garage?

As soon as Garage starts, there will be a constant recruitment of projects. The application form should contain:

• team of project
• goals of project
• schedule
• budget
• own resources
• needs of the project

Then, after the application, the Advisory Board will decide whether the project gain acceptance or not. After obtaining approval you have to sign regulations and ethical code.

First projects

At the end, dr. Warchoł gave examples of submitted projects to Garage Life Science. Here they are:

• elaboration of fluorescent labeling proctocol (FISH) single avian’s cells (in the scutellum germ of zebra finch) based on gender
• cel cultures and microfluidics
• expression, purifying and activity assays of protease TEV.

Creation of the Garage LifeScience is a chance for inventors and enthusiasts in the field of biotechnology to carry out projects (even those, that are forgotten, since there was not enough money to implement them), in an accessible form and on fair financial terms.

Artykuł Bio Hacker Space in Poland – Development of biotechnology in Krakow pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.