Protection of Regulatory Data in Life Sciences. At the intersection of IP, regulatory regimes and new technologies


The extraordinary development of highly advanced technologies in life sciences has gradually transformed how cutting-edge knowledge is protected by available legal instruments. The higher the degree of technological complexity of innovations in this field, the less likely they can be reverse engineered and imitated. Consequently, patents and SPC are no longer the most attractive instruments providing the competitive advantage in the life science sector, and the emphasis has been increasingly placed on trade secrecy and protection of regulatory data. The latter is provided in Europe via confidentiality and exclusivity of data submitted to regulatory agencies. Anchored in the regulatory requirements, these two protective regimes are concurrently an important part of the overall IP framework and, as such, need the highest possible coherence with other instruments protecting life science innovation. This, however, is easier said than done, and currently, the complex system of regulatory data protection poses numerous challenges for a well-thought, balanced IP system.

Our conference aims at contributing to the discussion on the current challenges to the protection of regulatory data. It is co-organised by the Department of Polish and European Industrial Property Law, the Centre of New Technologies and the Life Science Legal Lab, with the view of enhancing an open debate among scholars, students, practitioners, representatives of the Life Science industries and policymakers. The Polish Patent Office is an official partner of the event.

The conference will be held in a hybrid format. Due to health resons, the number of on-site participants is limited, therefore we kindly ask that participants who wish to visit us in Warsaw sign up as soon as possible. When registering, please make sure you check the appropriate box to indicate whether you will be joining us online or on site.


Download Program

Dr Żaneta Zemła-Pacud
Prof. INP PAN Helena Żakowska-Henzler
Prof. INP PAN Paweł Podrecki
Dr Tomasz Zimny
Dr Anna Miszczak
Gabriela Lenarczyk

Due to health reasons, a limited number of participants can be present at the conference venue. The registration for live participation will close once there are no more seats available, however, there is an unlimited number of slots for online participants.

Registration for online participation will close on 9 November 2022.

Registration link

Joanna Belowska

Joanna is a PhD candidate at ILS Polish Academy of Sciences, actively involved in Life Science Legal Lab works. She’s also a life science lawyer and associate at DZP Law Firm. She advises pharmaceutical companies on medicines reimbursement and other regulatory matters including market access cases with patent protection uncertainties.

Patent linkage system in Poland – expensive mistake or legal means to avoid trouble?

Patent linkage is a concept that aims to prologue the original company’s market monopoly, so the payer is financing the most expensive therapy on the market for at least six months more.

Patent protection and data and market exclusivity are supposed to encourage pharmaceutical and biotech companies to invest in R&D and innovative therapies. In the author’s view, based on, inter alia, the interpretation of the Polish Reimbursement Act and the EU law, the regulatory status of a medicinal product (including its reimbursement status) should not be linked to the patent status of the original medicine.

This presentation examines: (i) how patent linkage practices affect stakeholders with different interests: innovative companies, generic companies, public payers and patients; (ii) how Polish law and EU law see the patent linkage system and why the new draft of the Reimbursement Act links regulatory status of a medicinal product to a patent status; (iii) what are regulatory and economic consequences of a patent linkage issues.

In Poland, current interpretation that the patent status and regulatory status are separable from each other is consistent with the legislature’s presumption of rationality. The Ministry of Health has no tools to examine the existence of patent protection. It is also not a part of the reimbursement procedure as precisely defined in the Reimbursement Act. Consequently, from the public payer’s budget perspective, it is unjustified to withhold the reimbursement procedure of an equivalent solely because of patent protection that has not yet expired.

However, in recent years we have observed several cases with granted reimbursement status and patent protection uncertainties when as a consequence of patent disputes, a generic company could not deliver continuity of supplies leaving the patients without access to much- needed medicines.

The presentation will examine the Polish legal framework (existing and new, pending legislation) and Ministry of Health practice with examples of recent cases with patent linkage issues.

Professor Susy Frankel

Susy Frankel, FRSNZ, Professor of Law, holds the Chair in Intellectual Property and International Trade and is Founding Co-Director of the New Zealand Centre of International Economic Law, at Te Herenga Waka Victoria University of Wellington. Professor Frankel was President the International Association for the Advancement of Teaching and Research in Intellectual Property (ATRIP) from 2015-2017. She is a member of the editorial boards of the Journal of World Intellectual Property, Queen Mary Journal of Intellectual Property and the Intellectual Property Quarterly. She teaches copyright, trade marks, patents, international intellectual property and international trade law. Her scholarship focuses on international intellectual property and its nexus with international trade; particularly treaty interpretation; the position of developing countries and small market economies; and the protection of indigenous peoples’ knowledge and innovation. From 2008-2019 she was Chair of New Zealand’s Copyright Tribunal. In 2018 Susy was elected Fellow of the Royal Society of New Zealand and in 2019 was appointed a member of the Waitangi Tribunal, which hears claim brought to address government breaches of the Treaty of Waitangi.

“Mission Creep” in the Pharmaceutical Industry and its Impact on Innovation and Health (presented together with Jessica Lai) We will present part of our project that is concerned with patents and regulatory data exclusivity used to protect pharmaceuticals, including biologics. The project involves several jurisdictions and a considerable volume of data about pharmaceutical patents and regulatory applications and approvals. Overall, the project has three core outcomes:

  1. Qualitatively and quantitatively provide evidence of regime-shifting – the shift from a reliance on patents to a co-reliance on regulatory data exclusivity – in the pharmaceutical sector, in New Zealand, Australia, the European Union (EU) and the United States (US). This has involved searching for patent and regulatory review applications for several compounds and recording the data in a usable fashion. Within this data, we have seen effects of changes in the law (e.g. when New Zealand started allowing patents for new uses of known pharmaceuticals in 1997) and differences in behaviour of pharmaceutical entities across the different jurisdictions.
  2. Analyse the effects of this shift on: (a) innovation (which patents should ensure); and (b) public health and safety (which the regulatory review of medicines should ensure).
  3. Show how the interrelatedness of the legal regimes, and the tendency of law and policy to deal with these regimes as siloed frameworks, has allowed the pharmaceutical industry to have too much protection; hence how the system fosters “mission creep”.

In the presentation we will provide an overview of the project and illustrate the outcomes with examples from our case studies.

Daria Kim, Ph.D., LL.M

Daria Kim is a Senior Research Fellow at the Max Planck Institute for Competition and Innovation (Munich). She holds an MA (Indiana University of Pennsylvania), LLM (Munich Intellectual Property Law Center), and Dr iur (University of Augsburg) degrees and has worked and published on topics related to intellectual property and regulation of medical research, data-driven innovation and artificial intelligence (https://www.ip.mpg.de/en/persons/kim-daria.html).

Confidentiality of regulatory data

Confidential treatment of safety and efficacy data submitted for marketing authorisation of medicinal products has been highly controversial. The presentation will take a systematic look at the justification, the legal nature and the scope of different strands of legal protection that collectively and sometimes confusingly are referred to as ‘confidentiality’ of regulatory data. It will also outline normative considerations regarding data accessibility taking a historical and a post-pandemic, forward-looking perspective.

Jessica Lai, Ph.D.

Dr Jessica Lai is an Associate Professor of Commercial Law at Victoria University of Wellington, New Zealand. Jessica specialises in patent law, the protection of Mātauranga Māori, and patents and gender. Jessica is the author of Indigenous Cultural Heritage and Intellectual Property Rights (Springer, 2014) and Patent Law and Women (Routledge, 2022), as well as Patent Law and Policy (LexisNexis, 2016, with Susy Frankel). She is also an author of the Annotated High Court Rules (4th edn, LexisNexis, 2018), as well as numerous articles and chapters, and the editor of multiple books.

She studied law and chemistry at Victoria University of Wellington, where she obtained an LLB Hons (First Class), MSc (First Class) and BSc. Jessica completed her doctorate (summa cum laude) at the University of Lucerne, Switzerland, in 2012. She stayed on at the University of Lucerne as a postdoctoral researcher until July 2016. Between February 2015 and July 2016, she was concurrently a Swiss National Science Foundation Postdoctoral Fellow, allowing her to be a guest researcher at the Max-Planck Institute for Innovation and Competition in Munich. Jessica was named a Rutherford Discovery Fellow by the Royal Society of New Zealand in 2021.

“Mission Creep” in the Pharmaceutical Industry and its Impact on Innovation and Health (presented together with Susy Frankel) We will present part of our project that is concerned with patents and regulatory data exclusivity used to protect pharmaceuticals, including biologics. The project involves several jurisdictions and a considerable volume of data about pharmaceutical patents and regulatory applications and approvals. Overall, the project has three core outcomes:

  1. Qualitatively and quantitatively provide evidence of regime-shifting – the shift from a reliance on patents to a co-reliance on regulatory data exclusivity – in the pharmaceutical sector, in New Zealand, Australia, the European Union (EU) and the United States (US). This has involved searching for patent and regulatory review applications for several compounds and recording the data in a usable fashion. Within this data, we have seen effects of changes in the law (e.g. when New Zealand started allowing patents for new uses of known pharmaceuticals in 1997) and differences in behaviour of pharmaceutical entities across the different jurisdictions.
  2. Analyse the effects of this shift on: (a) innovation (which patents should ensure); and (b) public health and safety (which the regulatory review of medicines should ensure).
  3. Show how the interrelatedness of the legal regimes, and the tendency of law and policy to deal with these regimes as siloed frameworks, has allowed the pharmaceutical industry to have too much protection; hence how the system fosters “mission creep”.

In the presentation we will provide an overview of the project and illustrate the outcomes with examples from our case studies.

Takeshi S. Komatani, Ph.D., LL.M.

Takeshi S. Komatani holds a Ph.D. in pharmaceutical sciences and LL.M. in global legal practice and is IP Attorney-Pharmacist at SHUSAKU*YAMAMOTO, an IP/Law firm in Osaka, Japan, practicing patent and other IP matters in the field of pharma, biotech and chemistry. The author is also Ph.D. Researcher at Graduate School of Law, Keio University, Tokyo, Japan, doing academic research on the theme of regulatory data protection, as well as Visiting Professor at Graduate School of Science, Technology and Innovation, Kobe University, Hyogo, Japan, teaching innovation/IP strategy/entrepreneurship.

Protection of Regulatory Data in Japan: Different Regimes in the Far-East by means of “Reexamination/Reevaluation Periods”

Japan is a member of the TRIPS; however, Japan has no legal statute that defines regulatory data exclusivity as a matter of legal right. In this regard, TRIPS Art. 39(3) defines that such data should be protected against unfair commercial use. Being a member of TRIPS, Japan employs a so-called “reexamination period” system, which practically has the same functions as those of the regulatory data exclusivity in other jurisdictions such as EMA and FDA, in order to meet the TRIPS requirement. According to the applicable law in Japan, i.e., the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (“PMD Act”), a regulatory data exclusivity is granted by the Pharmaceuticals and Medical Devices Agency (“PMDA”) as a benefit of marketing authorization, under the supervision of the Ministry of Health, Labour and Welfare (“MHLW”), by means of “reexamination period.” During the reexamination period designated for an approved innovative pharmaceutical product, generic pharmaceutical entities cannot enter into the market relying on the data generated by the innovator company on which the approval of the innovative product was based. In other words, the PMDA discourages generic manufacturers from applying for drug approval during the corresponding reexamination period, particularly in view of safety reasons. As such, the reexamination period practically functions as a barrier against generic manufacturers to enter into the market, which practically has similar effects as the data exclusivity. The data exclusivity in terms of reexamination period is granted for pharmaceutical products or regenerative medicine products for human, as well as those categorized as animal health products, but not for medical devices. There are a variety of terms of exclusivity periods in terms of reexamination periods based on various types of approval reasons. For the purpose of agricultural products, exclusivity is defined in terms of “reevaluation period,” which has similar effects as the pharmaceutical reexamination period. As the data exclusivity in terms of reexamination/reevaluation period in Japan has only a practical effect, the confidentiality may not be directly provided by the exclusivity. Furthermore, according to several court decisions, it is understood that the regulatory data exclusivity in terms of the reexamination/exclusivity period cannot be enforced before the court as a legal right. In this presentation, pros and cons of such “uncertain” Japanese exclusivity system shall be introduced and discussed by comparing with those in other jurisdictions including EU and USA.

Gabriela Lenarczyk

Gabriela Lenarczyk is an Associate Researcher in the Institute of Law Studies at the Polish Academy of Sciences (ILS PAS). She graduated with a degree in law from the Jagiellonian University, Kraków and begun doctoral studies at ILS PAS shortly after. Her doctoral thesis, titled ‘Patent pledges against the background of Polish legal instruments, with particular emphasis on the License of Right’, has received positive reviews and will be defended in November 2022. Gabriela’s present research is focused on private ordering mechanisms in intellectual property and their role in facilitating open innovation in the service of greater access to medicines and environmental sustainability. She is a member of the Life Sciences Legal Lab formed within the ILS PAS, where she researches the use of Artificial Intelligence in the pharmaceutical industry and the increasing tension between commercial data protection and the principles of clinical data transparency.

As a practicing lawyer, Gabriela is an Associate at the Budzowska, Fiutowski & Partners law firm with vast experience in medical law. She is the co-chair of Young Lawyers Group at the Pan-European Organization of Personal Injury Lawyers and a member of the American Association for Justice (AAJ).

The new Clinical Trial Information System: between transparency and protection of commercially confidential information

Intellectual property law is an essential component of how access to scientific advances is structured. Safeguarding the right to health requires exercising caution in striking a balance between societal needs and the legitimate economic interests of sponsors. In the past, focus has mainly been placed on the relationship between access to medicines and patents or data exclusivity. However, the protection of commercially confidential information (CCI) contained in quality, safety and efficacy data collected in the process of obtaining regulatory approval of proposed medicines may equally create barriers to data and information that the public has vital interest in accessing.

The key objective of the EU Clinical Trial Regulation (CTR), which became applicable in January 2022, has been to strengthen transparency of clinical trial data. Whereas the CTR is not the first EU policy initiative aimed at increasing public access to clinical trials data, it substantially shifts the transparency requirements to earlier phases of clinical trials, establishing transparency needs throughout the whole process of clinical development. This presentation discusses whether the CTR has been successful in striking an adequate balance between the competing interests of transparency and confidentiality and, if not, which areas require improvement for the sake of a predictable system which enables controlled sharing of data, enhanced and incentivised within an open innovation paradigm and reconciled with adequate protection of commercial interests of data holders.

Professor Dr Duncan Matthews

Duncan Matthews holds a PhD from the London School of Economics and Political Science (LSE). He is the immediate past Director of the Queen Mary Intellectual Property Research Institute and a member of the Centre for Commercial Law Studies, Queen Mary University of London. He has over 26 years’ experience of teaching and researching intellectual property law and policy. He has acted as an advisor to the European Patent Office (EPO), the European Commission, the European Parliament, the UK Intellectual Property Office (IPO), the World Intellectual Property Organization (WIPO), the World Health Organization (WHO) and the Organisation for Economic Cooperation and Development (OECD).

He has been a Visiting Fellow at the Australian National University, (Canberra, ACT) and the University of Verona (Italy) and teaches as an international expert on the WIPO LLM Programme at the Jagiellonian University (Krakow, Poland) and on the WIPO Summer Schools at Charles University (Prague, Czech Republic) and Huazhong University of Science & Technology (Wuhan, People’s Republic of China). He has also taught at the Humboldt University of Berlin and the University of Freiburg (both Germany) and the Shanghai University of Political Science and Law (People’s Republic of China). He has delivered public lectures at São Paulo University (Brazil), the University of the West Indies (Mona Campus, Jamaica), at the University of London in Paris (ULIP, France).

He is the author of Globalising Intellectual Property Rights: the TRIPS Agreement (Routledge, 2002) and Intellectual Property, Human Rights and Development (Edward Elgar, 2011). He is the co-editor of the Research Handbook on Intellectual Property and the Life Sciences (Edward Elgar, 2017), He is currently co-editing (with Professor Paul Torremans, University of Nottingham) a Research Handbook on European Patent Law, which will be published by Walter de Gruyter GmbH in 2023.

Keynote Address

The protection of regulatory data in the life sciences can have profound implications for the twin objectives of the maintaining the innovation system and contributing to future public welfare. This keynote address will identify trends in regulatory data protection, regulatory exclusivities, confidentiality of regulatory data and patent linkage. In doing so it will highlight key issues at the intersection between IP, regulatory regimes and new technologies for further debate.

Anna Miszczak, Ph. D.

Anna Miszczak holds a PhD in legal science and MA in political science. She is the author and co-author of many publications concerning intellectual property law, especially patent law. Currently, she is associated with the Institute of Law of the Polish Academy of Sciences (PAS) and Faculty of Law of University of Social Sciences and Humanities (SWPS). She is one of the members of the research group LLSL (Life Science Legal Lab) conducted within the PAS. Anna is also an expert (in the field of IP) in one of the leading law firms in Poznań (Poland).

Revision of the EU general pharmaceuticals legislation

In 2020, a decision was made to start wide-ranging activities aimed at reforming the legal EU pharmaceutical system. It was then decided to completely revise everything known so far and to consider what and how can be changed to make the functioning of the pharmaceutical market in EU more effective. From the time when the “First step” project appeared two years ago, we were able to observe the actions of officials, learn about the opinions of different environments and get acquainted with the first effects of the Commission’s work. Why was the revision decision made? Which way are the changes going? What are their goals? What effect will they bring (or supposed to bring) to the EU? The presentation will be aimed at answering these and other questions.

Professor Frantzeska Papadopoulou

Frantzeska Papadopoulou is Professor of Intellectual Property Rights at the Law Faculty, and the Head of the IP Law Group in Stockholm University. She is the editor-in-chief of the Stockholm Intellectual Property Law Review and a member of the Advisory Board of the National Library of Sweden. She is the author of several books and articles such as ’Evergreening Patent Exclusivity in Pharmaceutical Products’ (Hart, 2021) and ’The Protection of Traditional Knowledge in Genetic Resources’(Elgar, 2017).

Keynote presentation: Regulatory Exclusivity in Pharmaceutical Products

In her presentation Frantzeska Papadopoulou will discuss and evaluate the legislative architecture of regulatory rights in the EU. The interaction of regulatory rights with the patent system and SPCs will be presented, having concrete cases as a starting point. What is the actual relation between regulatory rights and patent law and is it high time to adopt a helicopter perspective in the EU?  Finally, the presentation will reflect on future developments under the framework of the Unitary Patent Package.

Tomasz Targosz, Ph.D.

Tomasz Targosz specializes in intellectual property cases, in particular copyright and related rights as well as patent law, and, furthermore, in unfair competition, antitrust and consumer protection.

He is the author and co-author of publications on civil and commercial law, copyright law and new technologies law, including Internet law, advertising and promotion law, media and personality rights, abuse of legal personality, copyright transfer agreements, and copyright infringements.

Tomasz works in the Chair of Intellectual Property Law at the Jagiellonian University in Kraków. He is also a partner at the Traple Podrecki Konarski & Partners Law Office.

The law of unintended consequences: the curious case of Portugal

In 2011 a law was enacted in Portugal that was supposed to put an end to a controversy whether obtaining a marketing authorization was only an administrative act irrelevant for patentlaw or an act that could be regarded as infringement deciding the issue in favour of the former position. However, ostensibly to force patent owners and generic companies to settle any possible disputes before market entry patent owners (if they do not want to forsake future enforcement) must bring a special action within a maximum period of 30 days, counting from the date publication of the grant of the marketing authorization of the generic drug. This seems to have caused some (probably unintended) consequences.

Joanna Uchańska, Ph.D.

Joanna Uchańska, Ph.D., attorney-at-law and court mediatorx, specializes in IP and Regulatory in Life Science Sector. She is also focused on Compliance, Sustainability, Responsibility, and Brand Protection. The head of Life Science & Healthcare Department in Polish Law Firm. The lecturer to postgraduate students of Criminal Tax Law and Business Law, Medical Law, and Prevention and Combating Economic and Tax Crime (Department of Criminal Law of the Faculty of Law and Administration at the Jagiellonian University).

How regulatory data protection (RDP) can help to achieve ESG goals? – access to medicines perspective

The data is the new fuel – the cliché is broadly known. Patent-oriented companies were attractive to investors, and having a green or social-oriented invention and getting a patent for it would mean a more or less measurable higher ESG level. Nevertheless, patents and SPCs dedicated more or less to the traditional dominance of small-molecule drugs are no longer the most attractive instruments providing competitiveness on the market. So, whether RDP is more attractive for companies creates some problems when we think about ESG measuring – the question is how to manage without giving up on them.

Let’s present some issues worth discussing i.a.:

  1. what shall be know about ESG when we think about incentives to innovations;
  2. if the company has RDP, the reporting of such a policy should be disclosed;
  3. does RDP undermine access to medicines and what is the “S” factor when we think about;
  4. human rights? Consideration of the cost of RDP must also be weighed against the benefits that new medicine can bring. While RDP shields biologics manufacturers from biosimilar competition, it also incentives innovation which results in the development of biologic treatments and cures that might not otherwise come into existence (ex. orphan and pediatric drugs);
  5. when reporting, is it to clarify the “S” factor and human rights that RDP may be perceived as a step too far, or RDP is critical to securing sustained investment in biotech innovation; wherever the “S” factor may be totally increased because implementing or extending the term of RDP is unlikely to drive up health spending beyond existing trends;
  6. how the RDP strategy complements the scope of responsibility of the business strategy;
  7. regulatory authorities require data from pre-clinical and clinical trials to be able to approve and certify that a medicine is safe and effective for consumer use before market entry;
  8. thinking ESG, which risks in the light of RDP shall be taken into account: reputation, financing,
  9. responsibility, investment, and cost improvement; RDP is critical because it ensures that competitors cannot enter the market on the back of an innovator’s test data before the innovator has had a fair opportunity to recoup the costs of compiling it.

Consequently, RDP may have also impact on the ESG indicators – mostly “Social” and “Governance” areas. It is to answer how RDP can help to present ESG goals.

Victor van de Wiele

Victor is a doctoral candidate at the University of Cambridge under supervision of Dr. Kathleen Liddell at the Centre for Law, Medicine and Life Sciences. He is also an affiliated researcher at Harvard Medical School working with Dr. Aaron Kesselheim at the Program on Regulation, Therapeutics & Law (PORTAL). Victor holds an undergraduate degree in law & politics (LL.B) from Queen Mary, University of London and a masters degree (LL.M.) in Global Health Law (Food & Drug Law Certificate) from Georgetown University Law Center. Victor’s research has been published in journals like Nature Biotech, JAMA Internal Medicine and Health Affairs, and focuses particularly on how patents and patent litigation can form barriers to or delay market entry for generic and biosimilar drugs in the United States and Europe. Victor’s (preliminary) doctoral thesis title is: “a critical exploration of patent infringement proceedings available to new market entrants in the United States and the United Kingdom, and their impact on drug competition. Should the United Kingdom adopt a Special Litigation Process (SLP)?”

Patent Linkage and Pharmaceutical Competition in the United States – Should the European Union Adopt a Similar System?

The United States implemented a special litigation process (SLP) to resolve pharmaceutical patent disputes. First introduced by the Hatch Waxman Act of 1984 in the United States and reapplied in the Biologics, Price, Competition and Innovation Act of 2010, the process implements a legal concept called ‘a patent status condition’ (PSC). The PSC links the regulatory approval of a generic or biosimilar drug to the infringement status of unexpired patents covering the referenced originator drug. Although 90% of prescriptions in the US in 2021 were dispensed for generic and biosimilar drugs, the individual contribution of an SLP to a thriving generic drug market is unclear. Three factors create this ambiguity. First, US prescription drug spending per capita is the highest in the world. Second, the SLP has arisen in trade treaty negotiations with the US, but has been adopted differently among sixteen countries and termed unlawful by the European Union. Third, a detailed evaluation of the merits of the SLP does not currently feature in the existing literature. This presentation will (1) explain how both systems in the US work, (2) whether the SLP, considering its position amongst other conventional patent infringement proceedings, is essential to ensuring timely generic entry, and (3) explore the difficulties associated with adopting such a system in Europe. The conclusion of this presentation suggests more empirical research is needed to understand whether an SLP is essential to timely generic entry and whether, ultimately, the European Union should adopt it.

Żaneta Zemła-Pacud, Ph.D.

Żaneta Zemła – Pacud is Assistant Professor at the Institute of Law Studies at the Polish Academy of Sciences (ILS PAS). She graduated from Adam Mickiewicz University, Poznan, in both law and European studies. In 2012 she obtained her PhD at Cracow’s Jagiellonian University with a dissertation on patent protection for medicines, awarded by the Ministry of Science and Higher Education. Żaneta has published and presented extensively on technology protection, especially in the life sciences. She also has led and participated in several domestic and international research projects in the field of biotechnological inventions, AI in patent judiciary, IP in the health sector in Poland, and others. As an external expert, she served WIPO and PPO projects. As a visiting researcher, she carried out her research at the MPI for Innovation and Competition in Munich and at the LML Centre at the University of Cambridge. She has taught intellectual property law, patent law, and new technologies at several prominent Polish universities. Since 2021 she has led a Life Science Legal Lab at the ILS PAS. Her present research is centered around protection of regulatory data. Żaneta has also gained expertise in the Life Science practice as an Of Counsel in Traple Konarski Podrecki, one of the leading Polish law firms.

Market exclusivity. The scope of protection and the relevance for the pharmaceutical industry in Europe

According to recent pharmaceutical surveys, for above 30 per cent of innovative pharmaceuticals, the last form of protection to expire is market exclusivity. While the consequences of patent or SPC monopoly are well known, there has been hardly any discussion or case law concerning the content of market exclusivity as a stand-alone instrument for protecting medicinal reference products. In the presentation, I will outline the rules governing market exclusivity and argue that generic drugs can be manufactured and stored during the exclusivity period and that these activities can be performed only by the entity responsible for the generic drug but also by third parties.

Tomasz Zimny, Ph.D.

Tomasz Zimny works as an assistant professor at the Department of Polish and European Industrial Property Law of the Institute of Law Studies, Polish Academy of Sciences. In his research Dr. Zimny focuses on the phenomena and processes that emerge at the intersection of normative systems and life sciences. His publications mostly focus on the protection of biotechnological inventions, the regulation of academic research in the field of biotechnology, and on bioethics. Dr Zimny works as an attorney in the field of intellectual property law, civil law and the transfer of technology between the academic sector and the industry and is a member of the Committee of Biotechnology of the Polish Academy of Sciences.

Regulatory data protection in the process of GMO authorization in the EU. Between confidentiality and exclusivity.

The author presents legal instruments designed to protect the confidentiality of data delivered to competent authorities (both local and at the EU level) by individuals seeking authorization of various genetically modified (GMO) agricultural products in the EU. The solutions at the disposal of GMO developers, mostly focused around the protection of confidentiality of various kinds of data (e.g. personal data, DNA sequences, breeding patterns), are contrasted with solutions used in other areas of the sector, in particular the regulatory data exclusivity for novel foods. Authorization delays and costs are also factored in, to assess the efficiency of the current regulatory solutions.

Lavinia Brancusi, Ph.D.

Dr. Lavinia Brancusi (Brâncuși) an adiunkt at New Technologies Law Centre, Institute of Law Studies, Polish Academy of Sciences in Warsaw. She held her law degrees at Warsaw University, Faculty of Law (master, dr. iur.) with an awarded doctoral dissertation in design law. Previously she hold an academic position at Cardinal Stefan Wyszynski University in Warsaw with lectures in the field of Polish civil law, industrial property and unfair competition. She is also an of counsel at AOMB Intellectual Property in Warsaw. Her research interests cover cumulative protection in intellectual property, with a specific focus on product protection, functionality in trademark and design law as well as the interface between IP and competition rules, especially in relation to brands. More about her publications and presentations on www.laviniabrancusi.edu.pl

Professor Rafał Sikorski

Rafał Sikorski, PhD (Adam Mickiewicz University), LLM (Central European University), is a professor of law at the Adam Mickiewicz University in Poznań (Poland). His major research areas include patent remedies, the nexus between IP and competition law, standard essential patents, as well as various forms of private ordering in IP and particularly patent law. He has published on patent pools, access to standard essential patents, patent remedies, conflicts-of-law rules for IP contracts and IP infringement as well as copyright law. Results of his research appeared in books published by, for example, Edward Elgar, Cambridge University Press, Wolters Kluwer and C. H. Beck. At the Law Faculty of Adam Mickiewicz University, he teaches various courses on IP, civil law, private international law and European Union law. Rafal Sikorski is also an attorney-at-law at one of the leading Polish law firms where he advises clients in matters related to licensing and protection of IP.

Łukasz Żelechowski, Ph.D.

Assistant Professor at the Faculty of Law and Administration, University of Warsaw, Department of Intellectual Property Law. Director of the Postgraduate Studies in Intellectual Property Law. Dr iur. (University of Warsaw, 2009). Dr. hab. (University of Warsaw, 2020). Polish qualified patent attorney, Arbitrator at the Arbitration Court for Domain Names at the Polish Chamber of Information Technology and Telecommunications. Scholarship holder at the Max-Planck-Institute for Intellectual Property and Competition Law in Munich (2007), Visiting professor at the University of Ottawa, Faculty of Law (2012). He specializes in intellectual property law and civil law. Editor and contributor to the commentary “Prawo własności przemysłowej. Komentarz” [“Industrial property law. Commentary”], vol. VIII A and VIII B, of the series “Komentarze Prawa Prywatnego” [“Private Law Commentaries”], C.H. Beck [2021-2022].