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European Pharmaceutical Contractor

The Entitlement Dispute

Patents can represent a valuable business asset, thus it is hardly surprising that questions raised over invention ownership are common. Neil Coulson of Jones Day considers routes to reaching resolution

A CRO’s business is to run clinical trials for third parties. Invariably, the scope of the clinical trials and the terms on which they are to be conducted are defined in an agreement. But what if during the clinical trial the CRO sees an improvement or comes up with an idea and devises an invention? Who is entitled to own that invention? This article looks at the current position taken by the courts on entitlement to a patent (whether an application or a granted patent), and examines how the question will be approached and what factors will be taken into account.

SCOPE OF A WRITTEN AGREEMENT

It is common (and best practice) in agreements for clinical trials for there to be a clear definition of the rights of each party in relation to any inventions made during the course of the trials and which may arise from information that passes between the parties. Essentially, there are three options: ownership by one or other of the parties or joint ownership between them. As an aside, if any invention is to be held jointly, it is important to establish who will be responsible for the prosecution of the patent application and to allow each party to provide whatever assistance is necessary. All this is fine as long as the invention arises directly from the scope of the work that it is anticipated will be carried out under the agreement. So for a degree of certainty, the definition of the scope of the work to be carried out under the agreement should be as clear as possible. This means that everyone knows (or should know) where they stand (most of the time).

But what if, for example, the contract is silent on ownership of inventions, or if the invention devised is alleged to fall outside the scope of work (as defined in the agreement) or is allegedly formulated after the clinical trials are complete and an agreement is, on its face, terminated. Or indeed, what if there is no contract at all? Looking at each of these situations, the person devising the invention would appear to be entitled. But, as we shall see, this is not necessarily the case and the answers to the following questions will be determinative:


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Neil Coulson is a Senior Associate in the IP Group of Jones Day’s London office. He is an experienced patent litigator and has represented clients in numerous actions relating to patent infringement, validity and entitlement before the Patents Court, Court of Appeal, Patents County Court and the European Patent Office. He has presented technical evidence to court appointed experts before the Italian court in Milan, and has specifically advised on patent issues in the biotechnology, pharmaceutical and medical devices industries. Neil also advises clients on all transactional matters in these sectors, including research and development agreements, licensing and the exploitation of patented technology.
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