Daria Kim

Doktorandin und wissenschaftliche Mitarbeiterin

Immaterialgüter- und Wettbewerbsrecht

daria.kim(at)ip.mpg.de

Arbeitsgebiete:

Immaterialgüterrecht, Gesetzlicher Rahmen des Pharmasektors, Recht und Ökonomie der Innovation

Wissenschaftlicher Werdegang

Seit 2018
Doktorandin und wissenschaftliche Mitarbeiterin
Max-Planck-Institut für Innovation und Wettbewerb, München

Seit 2015
Doktorandin
The Law School of the University of Augsburg
(Doktorvater: Prof. Dr. iur. Ulrich M. Gassner)

2013 - 2015
Wissenschaftliche Mitarbeiterin
Rechtswissenschaftliche Fakultät (bei Prof. Bryan C. Mercurio), the Chinese University of Hong Kong

2012 - 2013
Wissenschaftliche Mitarbeiterin
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
Mitarbeiterin
Eifman Ballet, Farukh Ruzimatov Ballet Foundation and BDO International (St. Petersburg, Russia)

2007
Magister in Linguistik
Indiana University of Pennsylvania, USA

Stipendien und wissenschaftliche Preise

Fulbright-Stipendium für Magister-Studiengänge

Publikationen

Herausgeberschaften

Contemporary Issues in Pharmaceutical Law: Setting the Framework and Exploring Potential Policy Options (Routledge research in intellectual property), Routledge, New York 2017, viii + 249 S. (gemeinsam mit Brian Mercurio).

    Beiträge in Sammelwerken, Kommentierungen, Handbüchern und Lexika

    Rational Decision-making in Drug Approval Regulation and Innovation: Policy Analysis Perspective, in: Bryan Mercurio, Daria Kim (Hg.), Contemporary Issues in Pharmaceutical Patent Law - Setting the Framework and Exploring Policy Options (Routledge research in intellectual property), Routledge, London; New York 2017, 203 - 224.

      Aufsätze

      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 (gemeinsam mit Bryan C. Mercurio). DOI

      • 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 (gemeinsam mit Bryan C. Mercurio).

      • 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.

      Forschungspapiere

      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 S. (gemeinsam mit Reto M. Hilty et al.).

      • 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

      Stellungnahmen

      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 S. (gemeinsam mit Reto M. Hilty et al.).

      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 S. (gemeinsam mit Reto M. Hilty et al.).

      • 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
      • Also published as: Max Planck Institute for Innovation & Competition Research Paper No. 17-08
      • Chinese Translation of the Position Statement

      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 S. (gemeinsam mit Reto M. Hilty et al.).

      • 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

      Vorträge

      03/2018

      Access to Clinical Research Data: Is the paradigm shifting?

      Veranstalter: Medizinische Universität von Wien
      Ort: Wien, Österreich