The Patents Court confirms that clinical trials are not necessarily confidential

16.10.2014

Summary: In the recent case of AGA v Occlutech, the Court has held that clinical trials are not prima facie confidential, contrary to the position adopted by the EPO. Instead, the Court will apply English law principles to determine whether any express or implied duty of confidence exists.
In a decision dated 22 July 2014, the Patents Court declared AGA’s patent concerning a medical device to seal holes in the heart invalid due to lack of novelty and obviousness, but dismissed Occlutech’s objections based on added matter and obviousness. It noted that were the patents valid, Occlutech’s products would have infringed, save for some related products for which it would have granted a declaration of non-infringement.
The consideration of novelty is of particular interest. The court was required to decide whether there was any obligation of confidence relating to the use of the patented device in clinical trials in Bratislava pre-priority, as, if not, the trials would be considered a novelty destroying disclosure.
The parties agreed that the matter could be addressed based on English law principles. Mr Justice Roth noted that there was no express obligation of confidence and therefore went on to consider whether there was an implied or equitable duty of confidence. Importantly, he decided that there was no presumption of confidentiality simply because the device was used in a clinical trial. This approach was contrary to that adopted by the EPO during opposition, which held that the use of a device in clinical trials gives rise to a prima facie obligation of confidence.
Instead, the UK Patents Court considered that for a duty of confidence to arise, the Slovak doctors receiving the information must have known, or ought to have known, that it was fairly and reasonably to be regarded as confidential. It was clear from the doctors’ evidence that they did not regard the nature of the devices as confidential. In all the circumstances, the court considered that the devices were not provided in such a way as to imply a duty of confidentiality. The doctors were not embarking on a commercial venture and the disclosure was not made on a business-like basis and with some avowed common commercial object in mind (as per previous case law). It was clear that all concerned considered that the device was revolutionary and that the doctors would wish to speak about the trials. Therefore, the fact that there was written correspondence in advance of the trials, but that none of it related to confidentiality suggested that there was no intention to impart a duty of confidence. As such, the disclosure was novelty destroying.
Of note, AGA had an earlier patent for a similar product which the Patents Court had previously held was not infringed by Occlutech’s products. The Court identified that the existence of this earlier patent may have led the patentee to consider there to be no need to protect the confidentiality of its invention during the trials and to act accordingly.
This decision of the Patents Court identifies a further difference in approach between the EPO and national courts, with the UK Court refusing to accept a prima facie position on confidence, instead adopting a more fact based consideration. The decision highlights the importance of ensuring that clinical trials conducted pre-priority have robust and preferably express confidentiality obligations in place.

Claire Phipps-Jones

Author