Intellectual property in clinical trials

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:

• Patents (and utility models) – patents are granted for an invention in any technological field if it is new, based on an inventive step and industrially applicable. With an exclusive right to use the patented invention, others are prohibited to produce, sell, use, offer or import the product covered by a patent claim. Patent protection is considered the most powerful form of IP protection, particularly in the pharmaceutical sector.
• Copyrights – copyright laws protect literary and scientific works that are the intellectual creation of an author which has the exclusive right to copy, modify, distribute, perform and display the work.
• Trademarks – a trademark is used to identify a product. A sign suitable for distinguishing a product from those of another enterprise can be protected as a trademark. Once a trademark has been registered, its owner acquires the exclusive right to use it for the protected goods and services for which it is registered.
• Know-how – the abilities associated with and knowledge of procedural processes often qualify as valuable know-how. Typically, a medicine's manufacturing processes constitute valuable know-how and trade secrets, if not already constituting a patentable invention.
• Trade secrets – a trade secret is valuable information that is not (as a body or in the precise configuration and assembly of its components) generally known among or readily accessible to persons within the circles that normally deal with this kind of information. It has commercial value and is kept confidential by the company or person lawfully in control of the information.

Protection of clinical trial results in the European Union

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.

Additional IP protection in the European Union

Clinical trial results may also be protected in the European Union using the following methods:

• Supplementary protection certificates (SPCs) – patent owners (eg, medicine patent owners) can extend the term of patent protection from the expiry date of the patent protection term, subject to requirements, using SPCs.
• Regulatory data exclusivity – a marketing authorisation holder is protected from another marketing authorisation applicant being able to refer to the marketing authorisation holder's documentation of a medicinal product (eg, clinical and pre-clinical data being part of a dossier) for a term of eight years from the first marketing authorisation in the European Union.
• Orphan market exclusivity – medicines with orphan status benefit from 10 years of market exclusivity once they receive a marketing authorszation in the European Union. This encourages the development of medicines for rare diseases by protecting them from competition from not only the same but also similar medicines. Such medicines must not be marketed during this exclusivity period.
• Paediatric-use marketing authorisation (PUMA) – this is a dedicated marketing authorisation covering the indication(s) and appropriate formulation(s) for medicines developed exclusively for use in the paediatric population. PUMA is for medicines that are already authorised, no longer covered by an SPC or a patent that qualifies as an SPC, and exclusively developed for use on children.