Netherlands: The Importance Of An Explicit Secrecy Clause In Clinical Trials

Last Updated: 29 August 2012
Article by Joran Spauwen

European Patent Office, Board of Appeal, 7 July 2007, T 0007/07 (Ethinylestradiol and drospirenone for use as a contraceptive/BAYER PHARMA AG)

As most 'hands-on' experts will be aware, confidentiality is one of the key issues when applying for a patent. The invention for which protection is sought must not only be inventive, but also novel. This test of novelty includes all relevant disclosures with regard to the invention, even if these were made by the applicant himself. It does not only concern inventions or knowledge of 'competing' scientists. It is therefore crucial that a patentable invention remains secret until an application has been filed with an patent granting office. But this is easier said than done. Especially in more complex forms of research, the cooperation of third parties may well be required. Pharmaceutical clinical trials are a good example of this. Such medical-scientific research involving people is an important phase in the development of a drug, and automatically results in the situation that several outsiders will have access to the medicament. A recent decision of one Board of Appeal of the European Patent Office shows that it may be of crucial importance to have secrecy by human subjects in a clinical trial recorded explicitly.

The Board of Appeal ruled in opposition proceedings against a patent that had been granted for the birth control pill Yasmin of Bayer. Hexal, a German producer of generic drugs, filed an opposition against the granting and managed to convince the Board of Appeal to revoke the patent on appeal. The invention was considered not novel, because it belonged to so-called prior art. The reason for this was that Bayer itself had insufficiently protected the confidentiality when it performed its clinical trial, and had thus disclosed the invention.

It is not surprising in itself that a very narrow definition of the concept of novelty is used in European patent law. This definition was already determined by the European Patent Office in 1992 ( G 1/92, OJ 1993, p. 408). The precise circumstances that made Bayer's clinical trial problematic are nevertheless interesting. It was pivotal that the human subjects had not signed a confidentiality agreement at all. Bayer had only obligated the investigators to contractual confidentiality. Furthermore, the human subjects had taken pills home during the trial, and part of the unused pills had not been returned to the investigators. The Board of Appeal found that under these circumstances, the drug investigated had become publicly available.

Bayer had defended itself by arguing that there was an implicit confidentiality agreement. The earlier decisions referred to by Bayer (T 0152/03 en T 0906/01), in which implicit confidentiality was assumed, were not applicable in the opinion of the Board of Appeal. The Board reasoned that these cases concerned an implant and only a limited group of human subjects. For this reason, these human subjects were not able to inspect the invention or to pass it on to a third party, unlike in the case of Bayer's drug. Moreover, after the end of the trial of Bayer not all pills had been returned, so that Bayer had also de facto lost control over its invention.

Bayer also argued that the human subjects could not be bound by a confidentiality agreement for ethical reasons, because this would have impeded them from informing their primary physician of the trial. The Board of Appeal considered this argument to be paradoxical in light of the implicit secrecy alleged before. Eventually, the Board of Appeal ignored this defense, because it is not an exception to novelty destroying disclosures as set out in the European Patent Convention. This gives rise to an interesting question. If implicit secrecy cannot be assumed, it is necessary to have a confidentiality agreement. However, Bayer could be right in that a human subject has a legitimate interest in informing his primary physician of his participation in the clinical trial and the composition of the drug. Naturally, during the trial it is possible to consult the physician involved in the trial – who will often be obliged to observe secrecy by the organizer of the trial. After a trial it may happen, however, that a human subject seeks treatment from his primary physician and that it is necessary for this physician to be informed of the participation in the clinical trial for purposes of a careful treatment. The decision of the Board of Appeal seems to indicate that if this provision of information on ethical grounds is permitted, it may be novelty destroying. It could still be argued that the physician cannot disclose such information on grounds of his doctor-patient confidentiality. However, it is the question whether this duty of confidentiality includes the composition of the drug if there is no connection to the human subject.

It is interesting to note that in all regulations concerning secrecy and privacy, this topic is only scarcely mentioned. The European Directive on "Good Clinical Practice" (2001/20/EC) does, for instance, set the obligation to protect the data on the human subjects themselves. Furthermore, in The Netherlands, medical research ethics committees are obliged to sign a confidentiality agreement (see the Expertise Requirements of the Central Committee on Research Involving Human Subjects []). However, very little has been regulated when it comes to confidentiality regarding the drug and the relationship with the primary physician. Article 4.3 of the ICH Guideline for Good Clinical Practice [] only contains a recommendation to inform the primary physician.

The decision of the Board of Appeal puts sponsors and investigators in a clinical trial in a difficult position. On the one hand, they will want to protect secrecy for the purpose of the patent application, but on the other hand, human subjects should not be denied the possibility of proper treatment from a primary physician. Until there is more clarity in this field, it is important to choose a strategy on the basis of the considerations described above before organizing a clinical trial. We must wait and see whether other Boards will also concur with this decision. In any case, it is important that explicit arrangements are made with the human subject about confidentiality. The possibility should also be taken into account that, if a patent was already applied for before the start of a clinical trial, new applications of the drug may be invented during the trial. It is therefore always wise to anticipate such a situation by having a confidentiality agreement in place.

First published in the Kennedy Van der Laan newsletter - January 2012

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