Experimental use exception

The experimental use exception removes from the proprietor’s exclusive right acts done for experimental purposes relating to the subject matter of the patented invention. It is provided for by Article L. 613-5(b) of the French Intellectual Property Code and by Article 27(b) of the Agreement on a Unified Patent Court (UPC). It reflects the idea that a patent, granted in return for disclosure, should not stand in the way of advancing knowledge about the invention itself.

Scope of the exception

The exception covers tests aimed at verifying the teaching of the patent, studying the invention, testing its properties, or seeking improvements or new applications. Legal scholarship traditionally distinguishes experimentation on the invention, which is covered, from use of the invention as a research tool, which is not. According to the prevailing view, using a patented screening method to discover new molecules thus falls within the monopoly, even in a research laboratory, and constitutes infringement if not authorised.

Commercial purpose

A commercial purpose behind the experimentation does not necessarily exclude the exception, provided that the act relates to the subject matter of the invention and has a genuine research purpose, but the question remains debated. The exception does not, however, cover acts which, under the guise of testing, prepare or carry out commercial exploitation, such as manufacturing quantities exceeding the needs of the experiment or presenting the product to customers. The UPC will have to define the scope of the exception, drawing on national traditions that do not entirely coincide on this point.

Relationship with the Bolar exemption and clinical trials

Studies and trials required to obtain a marketing authorisation fall under a separate exception, provided for in paragraph (d) of the same Article L. 613-5 IPC, known as the Bolar exemption. Clinical trials may fall under either exception depending on their purpose, a trial studying the patented medicinal product itself being capable of constituting experimentation, whereas a trial conducted to compile a regulatory dossier falls under the Bolar exemption. The party relying on the exception bears the burden of establishing the facts that justify it.

Key points

The experimental use exception protects research on the patented invention, not use of the invention to conduct other research or to prepare a launch. Its boundary with commercial exploitation remains uncertain and is assessed case by case. The scientific purpose of each trial should be documented, quantities should be limited to the needs of the experiment and, for regulatory trials, it should be checked whether the Bolar exemption applies.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats litigates patent disputes before the Paris Judicial Court, the Paris Court of Appeal and the Unified Patent Court. Where the question arises in a real case, the useful moment is almost always before proceedings are issued.

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