Confidentiality of clinical trials

The case-by-case approach of the UK courts to the confidentiality of clinical trials is illustrated by the decision of Mr Justice Roth in AGA Medical Corportation v Occlutech (UK) Limited [2014] EWHC 2506 (Pat). This case concerns a patent owned by AGA Medical relating to a medical device for occluding defects in the atrial septum of the heart (EP(UK) 0957773). The priority date of the patent was 14 May 1996. AGA claimed infringement of the patent by occluders made by Occlutech, to which Occlutech counterclaimed for invalidity on a number of grounds.

A key issue on which the judge had to decide was whether the patent was invalid for anticipation, based on disclosure of the invention by one of its inventors, Dr Kurt Amplatz, during clinical trials. Dr Amplatz had provided the patented device to medical personnel at the Bratislava Children's University Hospital in September 1995, without any express obligations of confidence; the personnel were not asked to sign any form of confidentiality or non-disclosure undertaking. Therefore, the Patents Court had to decide whether the disclosure to the Slovak doctors placed them under an obligation of confidence in equity.

AGA submitted that a duty of confidentiality arose from the circumstances in which the procedures were being carried out, as a clinical trial of a new medical device. However, in his decision, Roth J held that there can be no such presumption arising purely on the basis that the disclosure took place in a clinical trial. Instead, confidentiality depends on the facts of the case. Here, the evidence from the medical personnel involved was that there was never an indication or impression of confidentiality. In particular, one of them, Prof Masura, had spoken about the device subsequently in briefing sessions with other doctors in the hospital and to a wider medical audience at a paediatric congress. This disclosure demonstrated that he did not perceive himself to be bound by a duty of confidence. In these circumstances, if the device was confidential, it was reasonable for Prof Masura to expect to have been told this, even if he was not asked to give a formal undertaking. Prof Masura could not be expected to have known that it was fairly and reasonably to be regarded as confidential. Roth J therefore concluded that the device was disclosed without any confidentiality restrictions before the priority date of the patent. Hence, the patent was invalid for anticipation.

pile of booksThis case illustrates that it cannot be assumed that a clinical trial on its own implies a duty of confidentiality that will protect the disclosure of an invention under English law. The court will instead examine the circumstances of each case on its own merits.

Read the full judgment

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Paul England

Paul is a senior associate and professional support lawyer in the Patents group based in our London office.