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12 August 2020
Clinical trial results may qualify for protection as IP rights and, as such, for commercialisation in the European Union.
IP rights constitute not only a competitive advantage (eg, when developing a more efficient or new product), but also commercial value (eg, being licensable to other companies). Clinical trial results may be protected and commercialised under the following types of intellectual property:
In order to commercialise clinical trial results, they must be protected by the parties involved (eg, sponsors, institutions, investigators or contract research organisations). Before conducting a clinical trial, the parties are recommended to contractually agree to reasonable terms under a clinical trial agreement (CTA), which may cover the following topics.
Confidentiality versus academic freedom
To ensure that clinical trial results do not become public and are not copied or lack novelty such that they no longer qualify for protection under IP rights, all parties must treat them as confidential. However, some institutions such as universities and medical centres have interests (eg, academic freedom and publication rights) which place limitations on potential confidentiality obligations. For example, strict confidentiality would interfere with an institution's mandate to pursue research and safeguard public welfare or prevent it from freely sharing and publishing research results. Therefore, parties should take these potential conflicts of interest into consideration when negotiating a CTA.
Commercialisation versus IP ownership
Clinical trial results often are not directly generated by research companies (eg, sponsors) but by means of involving service providers such as institutions or their employees. Depending on the jurisdiction, creators may own the IP rights to any created results. In order to use and commercialise clinical trial results, a research company must gain ownership of the results, or at least a right to use them, and/or the IP rights to the results. Specific IP regimes must be considered when negotiating respective terms under a CTA. For example, in some jurisdictions it is legally impossible to assign copyright to a work. In some jurisdictions there is the doctrine of 'work for hire', whereas in others, for some IP rights the employing company does not automatically gain any and all rights to results created by an employee. Depending on the applicable law and the kind of results and IP rights relating to the results, the parties must specifically negotiate terms of assignment and transfer of rights to the clinical trial results in order to ensure the chain of transfer.
Research purpose versus regulatory restrictions
In order to pursue research and develop new products, conducting clinical trials is essential to research companies. Results and data from clinical trials therefore are important assets. At the same time, research companies are subject to a strict regulatory environment because the research area refers to a sensible and legally strictly protected value: human life and health.
Thus, the conduct of a clinical trial itself as well as the handling of results (ie, whether it is the assignment of ownership to results or the transfer of such) is challenging from a legal perspective. It becomes even more challenging when personal data is involved, which is often the case with clinical trial results, unless the data is anonymised. When negotiating a CTA, the respective terms relating to each party's contractual responsibilities and regulatory obligations must be agreed on.
Clinical trial results may also be protected in the European Union using the following methods:
For further information on this topic please contact Magdalena Kotyrba or Tobias Maier at Eversheds Sutherland (Germany) LLP by telephone (+49 89 54565 0) or email (email@example.com or firstname.lastname@example.org). The Eversheds Sutherland (Germany) LLP website can be accessed at www.eversheds-sutherland.com.
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