Confidentiality, clinical trials and the patentability of medical devices

A case before the High Court in London last year showed that medical device manufacturers can lose patents granted to them on the basis of a novelty-destroying disclosure during clinical trials.

The case highlighted the different approach that courts in the UK could take to that of the European Patent Office when assessing the validity of European patents protecting products disclosed during clinical trials.

It means manufacturers wishing to trial their inventions before applying for patent protection need to make sure people coming into contact with their device during clinical trials know they are bound by obligations of confidentiality.

Clinical trial testing of medical devices and the question of novelty

In the course of developing new products, medical device manufacturers will necessarily conduct clinical trials to demonstrate the safety and effectiveness of those products. In some cases, there will be sufficient confidence in the therapeutic effectiveness, and commercial success, of a device to justify the cost of preparing and filing a patent application before clinical trials are conducted.

However, in other cases manufacturers may prefer to check whether the results of clinical trials support additional financial commitment in projects, including patent filings, and wait for clinical trials to be conducted before filing for patent protection for their devices.

For a patent to be valid, the invention covered by that patent must be novel. In other words, at the date on which the patent was first applied for there cannot have been any disclosure of that invention, otherwise the patent will lack novelty.

Novelty-destroying disclosures can come in any form, and are commonly in written form in patent documents, journal articles, abstracts and theses. However, demonstrations or uses of products can also constitute disclosures and result in subsequently filed patents being deemed invalid. Prior disclosure of a patented invention is only novelty-destroying if the disclosure is made available to the public and not under obligations of confidentiality.

The AGA v Occlutech case

Last year, the High Court in London ruled that there had been a novelty-destroying disclosure of AGA's European patent for a medical device which helps treat patients with a hole in their heart during a clinical trial conducted prior to the patent being filed. The Court ruled that the patent was invalid as a result.

The High Court's judgment was significant. It confirmed that there can be no assumption that a medical device's use in clinical trials is protected by confidentiality. According to Mr Justice Roth, a medical device's use in a clinical trials setting can constitute a disclosure to the public and therefore cause patents that have subsequently been filed for and granted to be revoked.

In the case, an inventor behind the AGA medical device had taken examples of the device to a clinical trial in Slovakia in 1995. The inventor had explained how the device could be used to three doctors, an anaesthetist and a nurse and oversaw the insertion of the devices into patients.

When AGA accused rival Occlutech of infringing its patent rights, Occlutech counterclaimed that the use of medical device in the Slovakian clinical trial was novelty-destroying to AGA's patent, which had been applied for in 1996 and granted in 2011.

There is a principal under European Patent Office (EPO) case law that clinical trials are assumed to be confidential. However, the High Court said that "there is no presumption of confidentiality simply because this was a clinical trial".

Instead, it considered whether AGA was owed a duty of confidence in accordance with legal tests set in previous cases handled by English courts, including in a dispute between the model Naomi Campbell and the Daily Mirror newspaper. The case law confirmed that a duty of confidence arises whenever a person receives information he knows or ought to know is fairly and reasonably to be regarded as confidential.

Mr Justice Roth concluded that there was no obligation of confidentiality placed on the Slovakian medical professionals when the disclosure of AGA's medical device was made to them in the clinical trial. He found that the disclosure was therefore novelty-destroying to the subsequently filed and granted patent.

In parallel proceedings before the EPO, the EPO reached an alternative view. It held that AGA's patent was invalid but not because there had been a novelty-destroying disclosure during the Slovakian clinical trial. On that point, the EPO maintained its principal that clinical trials are assumed to be confidential, and held that there had not been a prior disclosure of the patent made to the public which would invalidate the patent. The proceedings before the EPO are the subject of an appeal.

Lessons to learn from the case

The case highlights that there are two approaches for determining whether the disclosure of a medical device during a clinical trial prior to filing for patent protection will invalidate a subsequently-filed patent application.

There is the UK court test, where there is no presumption of confidentiality on the basis that disclosure was made during a clinical trial and where a duty of confidence will be assessed on the facts of each case, and there is the EPO test where it is assumed that any person involved in clinical trials is subject to confidentiality obligations.

Medical device manufacturers cannot predict in which jurisdiction they may require to defend a patent years down the line. They therefore should assume that the more restrictive UK test would apply and take steps to pre-empt future claims that the disclosure of their inventions in clinical trials are novelty-destroying. To do this, medical device manufacturers should try to ensure that everyone engaged in a clinical trial knows that they are bound by obligations of confidentiality.

This means they should require all individuals who will come into contact with their device in a clinical trial setting to sign non-disclosure agreements, and ensure that clinical trial agreements impose obligations of confidentiality on all individuals who will come into contact with it.

In addition, all correspondence about the clinical trial should clearly and expressly state that the trial is confidential and be marked as such.

Even if a patent application has already been filed covering the device which is to be trialled, these steps should still be taken as any improvements in the product not disclosed in the already-filed patent application could be the subject of a separate patent application in future.

Adrian Murray is a patent law expert in the life sciences sector for Pinsent Masons, the law firm behind Out-Law.com. A version of this article was first published by Scrip Regulatory Affairs.