Does a clinical trial render the pharmaceutical formulation used therein public?

As previously reported, the new Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Clinical Trials Regulation (CTR)) entered into full force on January 31, 2022.

Like its predecessor, the Clinical Trials Directive (Directive 2001/20/EC), the CTR poses a number of challenges. From a patent-law perspective, the requirements for clinical trials, which aim to ensure public transparency and safety for clinical trial participants, can be detrimental to the validity of patents filed to protect the formulation of a drug subject to the clinical trial.

In a recent decision, the Technical Board of Appeal of the European Patent Office (decision of 2 December 2022, case no. T 0670/20) addressed the novelty attack on a formulation patent based on tablets containing the formulation being handed out to patients not bound by confidentiality restrictions during a clinical trial. In a previous case, the Technical Board of Appeal (decision of 7 July 2011, case no. T 7/07) held that such conduct could constitute public use. However, in T 0670/20, the Technical Board of Appeal (BoA) reached a different conclusion.

Adherence to protocol and assurance of drug accountability are key

The BoA held that the trial participants had entered into a “special relationship” with the trial investigators by agreeing to use the provided medication according to instructions and to return unused medication. Further, the BoA held that the clinical trial at issue had been carried out in accordance with the EMA Guidelines for Good Clinical Practice, which explicitly require adherence to the prescribed protocol and assurance of drug accountability. Insofar, the investigators involved were required to monitor the return of unused tablets by the patient. Thus, the BoA did not consider the patients as members of the public with a view to tablets provided to them.

One should note that the BoA came to this conclusion although the trial participants were not only free from any confidentiality obligations, but in fact encouraged to discuss their participation in the clinical trial with their doctor, family members or friends. This which was regarded as enabling the patients’ informed decision for trial participation and therefore necessary for compliance with EMA Guidelines.

Lack of (contractual) penalty irrelevant

The BoA held that the “special relationship” between the trial participants and investigators was neither marred by the lack of confidentiality obligations on the patients nor the lack of (contractual) penalties should they not comply with the instructions on use and return of unused tablets. The mere risk of patients not complying with the latter – which the party attacking the validity of the patent did not try to substantiate – did not affect the BoA’s conclusion that the trial participants were not members of the public.

Insofar, the BoA distinguished this case from the T 7/07-case, where the BoA held that drug accountability had not been assured because the sponsor had “lost control” over the drugs since not all unused drugs had been returned.

TW comments

Those involved in drug development are, also from a patent law perspective, well-advised to carefully consider and document the setup of their clinical trials, how the drug under clinical review is handed out to the patients and how the latter is monitored.

The latest decision shows that compliance with EMA guidelines, also on the patients’ and investigators’ part, can aid in preventing a novelty-destroying disclosure during a clinical trial. However, existing case law equally proves that the Boards of Appeal’s assessment can turn on details of the individual case. The most recent decision therefore does not guarantee legal certainty on the issue.