Protecting Trade Secrets Under International Investment Law: What Secrets Investors Should Not Tell States

31 Pages Posted: 28 Mar 2016

See all articles by Daria Kim

Daria Kim

Max Planck Institute for Innovation and Competition

Date Written: November 23, 2015

Abstract

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.

Keywords: Clinical trial data; pharmaceutical foreign direct investment; investor-state arbitration; intellectual property; investment law

JEL Classification: O34

Suggested Citation

Kim, Daria, Protecting Trade Secrets Under International Investment Law: What Secrets Investors Should Not Tell States (November 23, 2015). John Marshall Review of Intellectual Property Law, Vol. 15 (2), 2016, Available at SSRN: https://ssrn.com/abstract=2754006 or http://dx.doi.org/10.2139/ssrn.2754006

Daria Kim (Contact Author)

Max Planck Institute for Innovation and Competition ( email )

Marstallplatz 1
Munich, Bayern 80539
Germany

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