Drug Evaluation Committee 2010-39 Procedures for Requesting a Clinical Trial by an In-Country Manager for a Clinical Trial (Part 3)
Related classification: Clinical trial contract procedures
First published: Jan. 2011
Question
In a clinical trial agreement with a National Supervisor for Clinical Trials, do intellectual property rights and research results obtained by conducting a clinical trial belong to the sponsor?
Background of the question
We are planning to enter into a two-party contract with a domestic caretaker of a clinical trial (i.e., B), and in response to the opinion in question No. 2008-50, we plan to prepare a contract by specifying the sponsor and the domestic caretaker in the clinical trial agreement. Therefore, the domestic manager of the clinical trial asked us if we can change the wording of the following contract.
(Before the change)
(Institutional form) Intellectual property rights and research results obtained through the conduct of this clinical trial shall belong to the Second Party.
(Proposed change)
"・・・・・・・・・・・・ (same as above) ・・・・・・・・・・・・・・・ shall belong to the sponsor.
Is it necessary to accept the change of wording to "the sponsor" who is not the contractor?
JPMA's Opinion
No. The domestic manager of a clinical trial acts as an agent of the sponsor when conducting a clinical trial in Japan. Therefore, in general, intellectual property rights and research results obtained through a clinical trial are considered to belong to the sponsor, not the in-country caretaker of the clinical trial. We recommend that you confirm the attribution of the research results, etc. with the NMT and set the contents of the contract accordingly.