Product directly obtained by a patented process

Protection of the product directly obtained by a patented process extends the right conferred by a process patent to the product resulting from use of that process. It is provided for by Article 64(2) of the European Patent Convention (EPC), Article L. 613-3 of the French Intellectual Property Code and Article 25 of the Agreement on a Unified Patent Court (UPCA), in line with Article 28 of the TRIPS Agreement. The proprietor may thus prohibit the offering, placing on the market, use, importation and stocking of that product.

The requirement of direct obtention

Protection covers only the product directly obtained by the process. A product is regarded as directly obtained where it results immediately from the process, or where it has subsequently undergone only changes that do not affect its essential characteristics. It loses that link where it has been subjected to further processing that substantially alters its nature. The question is particularly acute for chemical synthesis intermediates and biological products, whose manufacture involves many successive steps.

Burden of proof

Proof that a process is used in a foreign plant or at a competitor’s premises is often beyond the proprietor’s reach. Article 34 of the TRIPS Agreement therefore provides for a reversal of the burden of proof, taken up in Article L. 615-5-1 IPC and Article 55 UPCA. Where the product obtained by the patented process is new, or where an identical product has very probably been obtained by that process and the proprietor has been unable, despite reasonable efforts, to determine the process actually used, the court may order the defendant to prove that its process is different, failing which the product is presumed to have been obtained by the patented process. The defendant’s legitimate interests in protecting its manufacturing secrets are taken into account. In France, saisie-contrefaçon remains the preferred tool for establishing the process used.

Relationship with other concepts

Protection of the directly obtained product must not be confused with the product-by-process claim, which protects the product itself, provided that it is new and inventive, whatever the process used to obtain it. It does, on the other hand, allow action to be taken against imports of products manufactured abroad using the patented process, including from a country where the patent does not exist. It is of particular interest to the pharmaceutical industry, where patents on a manufacturing process invention may outlive the patent on the active substance.

Key points

A process patent also protects the product directly resulting from it, and thus allows action against imports of products manufactured abroad. In practice, the debate centres on whether the product is directly obtained and on proof of the process used. It should be checked whether the product is new, a condition for the presumption, and evidence should be gathered through saisie-contrefaçon or analyses in order to trigger the reversal of the burden of proof.

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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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