Dr. Daria KimWissenschaftliche Referentin
Immaterialgüter- und Wettbewerbsrecht
Immaterialgüterrecht, Gesetzlicher Rahmen des Pharmasektors, Recht und Ökonomie der Innovation
Wissenschaftliche Referentin Max-Planck-Institut für Innovation und Wettbewerb, München
2018 – 2021
Max-Planck-Institut für Innovation und Wettbewerb, München
2015 – 2021
Promotion an der Universität Augsburg bei Prof. Dr. iur. Ulrich M. Gassner, Mag. rer. publ., M. Jur. (Oxon.) zum Thema "Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law"
2013 – 2015
Rechtswissenschaftliche Fakultät (bei Prof. Bryan C. Mercurio), the Chinese University of Hong Kong
2012 – 2013
Max-Planck-Institut für Innovation und Wettbewerb, München
2010 – 2011
LL.M. in Intellectual Property and Competition Law
Munich Intellectual Property Law Center (MIPLC)
2007 – 2010
Eifman Ballet, Farukh Ruzimatov Ballet Foundation and BDO International (St. Petersburg, Russia)
Magister in Linguistik
Indiana University of Pennsylvania, USA
Stipendien und wissenschaftliche Preise
Promotionsstipendium des Max Planck Instituts für Innovation und Wettbewerb
Fulbright-Stipendium für Magister-Studiengänge
Contemporary Issues in Pharmaceutical Law: Setting the Framework and Exploring Potential Policy Options (Routledge research in intellectual property), Routledge, New York 2017, viii + 249
Monographien und andere selbständige Publikationen
Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law (forthcoming), Springer, Berlin 2021.
Beiträge in Sammelwerken, Kommentierungen, Handbüchern und Lexika
Pharmaceutical and Agro-Chemical Test Data Exclusivity, in: Enrico Bonadio, Patrick R. Goold (
Incentives for Data-Sharing as a Case on (Regulating) Knowledge Externalities, in: In Honour of Hanns Ullrich, Springer, Berlin 2021, forthcoming.
Rational Decision-making in Drug Approval Regulation and Innovation: Policy Analysis Perspective, in: Bryan Mercurio, Daria Kim (
Redundant Trials Can Be Prevented, if the EU Clinical Trial Regulation is Applied Duly, BMC Medical Ethics 21 (2020) (
- The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.
'AI-Generated Inventions': Time to Get the Record Straight?, GRUR Int 69, 5 (2020), 443 - 456. DOI
- This article attempts to clarify the notion of an ‘AI-generated’ invention, an issue which has triggered an intense debate on the future of patent law and policy. While there is a general consensus that such inventions are incompatible with the concept of human inventorship, it remains largely unclear to what extent concerns regarding ‘non-human’ ingenuity can be justified. Most uncertain is how AI ‘autonomously generates’ inventions, and in what way 'AI-generated' inventions differ from inventions developed with the aid of AI. Drawing on the extensive literature review, this article depicts AI techniques as methods of computational problem solving. It emphasises that such methods should not be equated with a computer’s ‘cognitive autonomy’. Further, it clarifies that the types of AI that have been most debated in the patent law literature ‒ artificial neural networks and evolutionary algorithms ‒ essentially require detailed instructions that determine how the relation between inputs and outputs is derived through computation. Accordingly, it is argued that, as long as computers rely on instructions defined by a human as to how solve a problem, the separation between human and non-human (algorithmic) ingenuity is, in itself, artificial. Ultimately, the article calls for a broader technical inquiry that would elucidate the relevance of the currently debated normative concerns over ‘non-human inventorship’ against the background of the technological state of the art.
Transparency Policies of the European Medicines Agency: Has the Paradigm Shifted?, Oxford Medical Law Review 25, 3 (2017), 456 - 483. DOI
- This article reflects on the state of play as regards access to non-summary clinical trial data in the European Union (EU). In particular, it examines the scope of access under the recent transparency policies of the European Medicines Agency (EMA) that attempt to break away from the presumptively confidential treatment of clinical trial data. In light of the emerging case law of the Court of Justice of the European Union on clinical trial data disclosure, it remains highly uncertain what data, and under what conditions, can be lawfully released by the EMA. Under the applicable regulations, the scope of the accessible data depends on the interpretation of commercially confidential information—the notion derived from the exception to the fundamental right of access to documents. Accordingly, the analysis focuses on the application of this exception, taking into account the specifics of clinical data, the context in which disclosure occurs, and the interests that are at stake. The main complexity is found in defining the scope of the relevant and legitimate interests to be balanced when applying the exception. Overall, it is argued that the current regulatory framework does not provide a sufficient legal basis to support the objectives pursued by the EMA’s policies.
No One's Ownership as the Status Quo and a Possible Way Forward: A Note on the Public Consultation on Building a European Data Economy, GRUR Int 66, 8/9 (2017), 697 - 705.
- From 10 January to 26 April 2017 the European Commission carried out a public consultation on Building a European Data Economy. The key legal question of the initiative is how access and use rights in industrial data, as a digital resource, should be defined and allocated in order to achieve the objectives of the EU data-driven economy. The present analysis focuses on the proposals for new rights in industrial data, and takes a methodological perspective of designing a regulatory intervention. The overall argument is that the ‘intervention logic’ behind the proposals for a data producer’s right does not appear straightforward, and that keeping the scenario of non-intervention by such rights might not be the least optimal option among the possible ‘ways forward’.
- Also published in Journal of Intellectual Property Law & Practice 13,2 (2018), 154 - 165
Protecting Trade Secrets under International Investment Law: What Secrets Investors Should Not Tell States, John Marshall Review of Intellectual Property Law 15, 2 (2016), 999 - 1027.
- The article addresses specifics of trade secret protection under international investment law. As a particular example, it analyzes protection of pharmaceutical regulatory data against the background of the growing public policy campaign for broader access to clinical trial data and the recent unprecedented practice of the European Medicines Agency of disclosing clinical dossiers submitted for drug marketing approval. Given the significant role of foreign direct investment in the global pharmaceutical industry and substantial, exponentially increasing costs incurred by drug originator companies in conducting clinical trials, the prospect of investor-state dispute over data disclosure does not appear purely hypothetical. The question is whether investor-state arbitration is an apt instrument to protect originators' data against disclosure by drug regulatory authorities. The analysis suggests that the application of standards of international investment protection depends on the specifics of information at issue, its value, and functions in investors' commercial operations. With regard to pharmaceutical test data, it is argued that the prospects of investor-state arbitration are rather unfavorable for the investor, when data is disclosed to support policy objectives in public healthcare and medical innovation.
Knowledge Sharing as a Social Dilemma in Pharmaceutical Innovation, Food and Drug Law Journal 71, 4 (2016), 673 - 709.
- This article addresses the problem of restricted access to industry-sponsored clinical trial data. In particular, it analyzes the intersection of the competing claims that mandatory disclosure of pharmaceutical test data impedes drug sponsors' innovation incentives and that access facilitates new drug development. These claims are characterized in terms of public-good and common-resource dilemmas. The analysis finds confidentiality protection ofprimary research data plays an ambiguous role. While secrecy, as such, does not solve the public-good problem in pharmaceutical innovation (in the presence of regulatory instruments that protect the originator drug against generic competition), it is likely to exacerbate the common- resource problem, in view ofdata as a source ofscientific knowledge. It is argued that the claim by the research-based industry that disclosure of clinical data impedes innovation incentives is misplaced and should not be leveraged against pro-access policies. While much attention has been paid to the problem ofappropriability ofdrug R&D investment, this analysis highlights another consequence resulting from the private provision of clinical trials, i.e., factual confidentiality and possession of data by drug sponsors. The associated social costs are qualified in terms of internalized knowledge externalities. Since, in a competitive environment, companies are unlikely to change the strategy of non-sharing of primary data, the resulting economic inefficiencies at the sector level call for regulatory intervention. To reconcile the competing policy objectives, it is proposed that the rules ofaccess should be designed in such a way that third-party use of primary data does not interfere with protection against generic competition. At the same time, the long-term collective benefit can be maximized when the "cooperative choice" (i.e., when everyone shares data) becomes the "dominant strategy." This can be achieved only when access is not subject to the authorization of the initial trial sponsors, and when primary data is aggregated, refined, and managed on the collective basis.
Foreign Direct Investment in the Pharmaceutical Industry: Why Singapore and not Hong Kong, Asian Journal of Comparative Law 10, 2 (2015), 235 - 257 (
- This article began as mere curiosity over what appeared to be a paradox – Singapore and Hong Kong share countless economic and geopolitical similarities and compete vigorously for foreign direct investment (FDI), yet only the former has become a pharmaceutical hub while the latter struggles to attract any FDI in the sector. To find the reason for the “drastic” difference in pharmaceutical FDI, we compare the economic, legal, policy, and regulatory frameworks of the two jurisdictions focusing on the factors that have been identified in the economic literature as having the most relevance for FDI decision-making. The analysis discounts economic and legal factors before finding variances in policy and regulatory frameworks as the critical difference accounting for the disparity in the pharmaceutical FDI. Given that Hong Kong occasionally considers transforming itself into the “pharmaceutical centre for the Asia-Pacific”, this article calls for a change in policy approach and strategy before this aspiration is considered more realistically.
Enabling Access to Clinical Trial Data: When is Unfair Use Fair?, Chicago-Kent Journal of Intellectual Property Law 14, 2 (2015), 521 - 552.
- This inquiry is prompted by the unprecedented policy of the European Medicines Agency that enables the disclosure of clinical trial reports submitted for drug marketing authorization, effective as of January 1, 2015. It addresses the question whether such practice is in compliance with the international standard of clinical data protection under Article 39.3 of the TRIPS Agreement. Most scholarly and policy debate regarding this provision analyzes whether it precludes the referential use of data to facilitate the approval of a generic drug. Rather than focusing on a particular use, this Article seeks to identify the principle underlying the protection obligation by which the legitimacy of "use X" can be evaluated. In doing so, it interprets the provision from literal, historical and teleological perspectives, and it analyzes a peculiar overlap between three legal regimes: unfair competition, trade secret, and suigeneris data protection. The proposed principle allows avoidance of situations where, due to the ambiguous notion of unfair commercial use, the protection of data under the TRIPS Agreement can be stretched indefinitely. With regard to data disclosure for experimental use, it is argued that the protection obligation under 39.3 TRIPS does not justify monopoly type protection of clinical trial data, neither does it require the reservation of experimental use exclusively for the data originator, even if such use can have commercial benefits for competitors.
Patently Lacking: A Call for Systemic Review of Pharmaceutical Law and Policy - A Case Study of Hong Kong, Asian Journal of WTO & International Health Law and Policy 9, 1 (2014), 63 - 122 (
- This article offers preliminary findings into the pharmaceutical laws and policy of Hong Kong. Applying a framework approach to identifying the linkages between pharmaceutical patents and policy objectives in the areas of public health, medical innovation and pharmaceutical industry development, the article examines the pharmaceutical patent regime as an integrated system of patent and regulatory laws which govern pharmaceutical patents and products and explores the way such provisions operate at a complex intersection of policy objectives, priorities and mandates. The study reveals contradictions in the way in which the provisions are implemented within Hong Kong's pharmaceutical patent system as well as certain discrepancies between the system and broader governmental agendas. In so doing, the article demonstrates the importance of clear policy objectives in intellectual property, innovation and pharmaceutical industry as well as the need for sector specific empirical studies and an integrated approach for establishinga better functioning pharmaceutical patent regime. The perspectives and considerations revealed in the analysis are of interest and applicable to other jurisdictions in that they provide a framework for policy and law makers to implement pharmaceutical legal and regulatory provisions in a more coherent and systematic manner conducive to national priorities and balancing interests and needs of the stakeholders and the populace.
Position Paper on the Envisaged Reform of the German Patent Act (Max Planck Institute for Innovation & Competition Research Paper, No. 20-05), 2020 (
- This position paper of the Max Planck Institute for Innovation and Competition provides comments on the amendments proposed by the German Ministry of Justice and Consumer Protection in its discussion draft of January 2020 on the modernization and simplification of the German Patent Act. While the Institute generally welcomes the initiative, the paper offers some suggestions aimed at increasing precision in the areas of first, the concept and the implementation of the proportionality test for granting injunctive relief, and, second, the need for enhanced protection of trade secrets in patent disputes. With regard to the proportionality assessment, the Institute suggests that, rather than reducing it to an application of the principle of good faith, the concept of proportionality should be interpreted and applied in light of the ratio legis of patent protection with a view to preventing dysfunctional effects potentially resulting from the exercise of the exclusive right and the associated claim to an injunction. Scenarios involving complex products, non-practicing entities and standard-essential patents are used to illustrate the approach. As regards the weighing and balancing of interests when assessing proportionality, the position paper argues that it is neither desirable nor appropriate to prioritize the interests of the patentee over those of the infringer as a matter of principle. In addition, it is not only the interests of parties to the dispute, but also those of third parties, in particular the public interest, that should be taken into account. With regard to the protection of trade secrets in patent disputes, the position paper refers to certain procedural insufficiencies of the Trade Secrets Act to adequately protect the defendant’s secrecy interests. It also points out a potential loophole in relation to the 'Düsseldorf proceedings' that may facilitate 'fishing expeditions'.
- Available at SSRN
- German version at SSRN under the title: Stellungnahme zum Diskussionsentwurf eines zweiten Gesetzes zur Vereinfachung und Modernisierung des Patentrechts published as: Max Planck Institute for Innovation & Competition Discussion Paper No. 16
Technical Aspects of Artificial Intelligence: An Understanding from an Intellectual Property Law Perspective (Max Planck Institute for Innovation & Competition Research Paper, No. 19-13), 2019, 15
- The present Q&A paper aims at providing an overview of artificial intelligence with a special focus on machine learning as a currently predominant subfield thereof. Machine learning-based applications have been discussed intensely in legal scholarship, including in the field of intellectual property law, while many technical aspects remain ambiguous and often cause confusion. This text was drafted by the Research Group on the Regulation of the Digital Economy of the Max Planck Institute for Innovation and Competition in the pursuit of understanding the fundamental characteristics of artificial intelligence, and machine learning in particular, that could potentially have an impact on intellectual property law. As a background paper, it provides the technological basis for the Group’s ongoing research relating thereto. The current version summarises insights gained from background literature research, interviews with practitioners and a workshop conducted in June 2019 in which experts in the field of artificial intelligence participated.
- Available at SSRN
Stellungnahme zum Diskussionsentwurf eines Zweiten Gesetzes zur Vereinfachung und Modernisierung des Patentrechts, 2020, 16
- Das Max-Planck-Institut für Innovation und Wettbewerb nimmt hiermit zum Diskussionsentwurf eines Zweiten Gesetzes zur Vereinfachung und Modernisierung des Patentrechts Stellung, der vom Bundesministerium der Justiz und für Verbraucherschutz im Januar 2020 vorgelegt wurde. Das Institut begrüßt die Initiative des Ministeriums, empfiehlt im Hinblick auf die Beschränkung des patentrechtlichen Unterlassungsanspruchs und die Stärkung des Schutzes von Geschäftsgeheimnissen in Patentstreitsachen jedoch gewisse Präzisierungen. Mit Blick auf die Beschränkung des Unterlassungsanspruchs nach Maßgabe des Grundsatzes der Verhältnismäßigkeit wird vorgeschlagen, die Verhältnismäßigkeitsprüfung nicht auf einen Anwendungsfall der Gebote von Treu und Glauben zu reduzieren, sondern im Sinne der ratio legis des Patentrechts zu verstehen; insoweit als Maßnahme zur Verhinderung dysfunktionaler Effekte des Ausschließlichkeitsrecht bzw. des damit verbundenen Unterlassungsanspruchs. Zur Veranschaulichung des Ansatzes wird auf die Fallgruppen der komplexen Produkte, der Patentverwerter und der standardessenziellen Patente Bezug genommen, ohne sie jedoch im Detail durchzuprüfen. Mit Blick auf die im Rahmen der Verhältnismäßigkeitsprüfung vorzunehmende Interessenabwägung wird darauf hingewiesen, dass die Interessen des Patentinhabers gegenüber jenen des Verletzers keinen grundsätzlichen Vorrang genießen. Darüber hinaus sind bei der Abwägung nicht nur die Interessen der Streitparteien, sondern auch jene Dritter, insbesondere das öffentliche Interesse, zu berücksichtigen. Mit Blick auf den Schutz von Geschäftsgeheimnissen in Patentstreitsachen verweist die Stellungnahme auf Unzulänglichkeiten des Verfahrens in Geschäftsgeheimnisstreitsachen, die durch die angedachte Anwendung der entsprechenden Vorschriften auf das Patentstreitverfahren übertragen werden. Hingewiesen wird auch auf eine mögliche Regelungslücke in Bezug auf das "Düsseldorfer Verfahren", die von Patentinhabern für sog. "fishing expeditions" ausgenutzt werden könnte.
- Also published at SSRN as Max Planck Institute for Innovation & Competition Discussion Paper No. 16
- English version published under the title: Position Paper on the Envisaged Reform of the German Patent Act as Max Planck Institute for Innovation & Competition Research Paper No. 20-05
Comments of the Max Planck Institute for Innovation and Competition of 11 February 2020 on the Draft Issues Paper of the World Intellectual Property Organization on Intellectual Property Policy and Artificial Intelligence, 2020, 9
Position Statement of the Max Planck Institute for Innovation and Competition of 26 April 2017 on the European Commission's "Public consultation on Building the European Data Economy", 2017, 13
- This Position Statement responds to the Communication of 10 January 2017 by which the European Commission launched a public consultation on the future legal framework for data-driven markets that emerge in the course of the current digitization of industrial production and the advent of smart products in which sensors are embedded. In particular, the Position Statement comments the Commission’s ideas on a possible future data producer’s right as a means of promoting access to data. While the Max Plank Institute agrees that there are indeed instances where there is a need to “unlock data”, it rejects a data producer’s right. Rather, the Institute recommends considering more targeted data access rights that would specifically react to situations in which a manufacturer of smart products would otherwise try to reserve related markets for itself. The Max Planck Institute thereby takes inspiration from the data portability right that has already been implemented as part of the Basic Data Protection Regulation. Moreover, general principles on the design of data access regimes are developed. In sum, the Max Planck Institute favours a sector-specific approach to the introduction of a general data access right or a generally applicable data access regime. Sector-specific rules are especially needed for answering more concrete questions such as regarding the person entitled to claim access or the one of whether a data holder should be remunerated for granting access to data.
- MPI_Statement_Public_consultation_on_Building_the_EU_Data_Eco_28042017 Copy.pdf
- Chinese Translation of the Position Statement
- Also published as: Max Planck Institute for Innovation & Competition Research Paper No. 17-08
Position Statement of the Max Planck Institute for Innovation and Competition of August 16, 2016 - On the current debate on exclusive rights and access rights to data at the European level, 2016, 12
- Also published in GRUR Int under the title: Ausschließlichkeits- und Zugangsrechte an Daten - Positionspapier des Max-Planck-Instituts für Innovation und Wettbewerb vom 16.8.2016 zur aktuellen europäischen Debatte, GRUR Int 65,10 (2016), 914 - 918
- This position statement of the Max Planck Institute for Innovation and Competition has been released against the background of the European Free Flow of Data Initiative of the European Commission and the on-going political, economic and academic debate on the related issues. The Institute takes a stance as regards the introduction of exclusive rights in data, special legal protection of algorithms used in data analysis, as well as the questions on the applicability of the current EU legal framework for the sui-generis database rights and trade secrets to individual data and data-sets. The Institute sees no economic justification for the introduction of new exclusive rights in data, which could even hamper the functioning of the data-driven economy. In contrast, the statement emphasizes the importance of access to data in order to ensure the proper functioning of data-driven markets. It identifies the need for further research in this regard and recommends the general approach and principles to be considered if the special regulation of access to data is necessary.
- Positionspaper-Data-Eng-08-31_def-korr Copy.pdf
- Also published as: Max Planck Institute for Innovation & Competition Research Paper No. 16-10 under the title: Data Ownership and Access to Data - Position Statement of the Max Planck Institute for Innovation and Competition of 16 August 2016 on the Current European Debate
IP & KI: A Policy Perspective
Alumni-Konferenz, Max-Planck-Institut für Innovation und Wettbewerb
Access to Clinical Research Data: Is the paradigm shifting?
Veranstalter: Medizinische Universität von Wien
Ort: Wien, Österreich