Patents and Utility Models: Infringement

The extent to which generic manufacturers can research into products protected by patents before the patents have expired has been the subject of a decision in Germany, which allows such research within certain limits, and in an ECJ case referred from The Netherlands (Generics v SKF). Even if a competitor can carry out research into a pharmaceutical product before the relevant patent expires, it may have to wait until sometime after expiry before it can market its competing equivalent.

Germany

"Research" during the life of a patent - Clinical Trials II

Under the German Patent Act (Patentgesetz) of 1981, the owner of a patent cannot prohibit others from using the object of his patent for research or experimental purposes.

The Federal Supreme Court (Bundesgerichtshof - BGH) has now decided ("Clinical Trials II") that whether experiments may be carried out during the life of a patent does not depend on the motivation behind them. The owner of the patent may only take action against the tests if they cannot objectively be shown to relate to the testing of or research into the object of the patent or if the tests were so numerous that they could not possibly relate to research or experiment.
This decision has made it clear that "generic" manufacturers may carry out clinical trials needed for regulatory approval during the patent's life.

The current legal position in Germany therefore contrasts with the position in the UK and The Netherlands, where respectively, clinical trials and the supply of samples to regulatory authorities (see the Cimetidine decision below) to gain consent to market the product after the patent has expired amount to infringement. It also appears to run contrary to the principle of Supplementary Protection Certificates for pharmaceuticals, which are designed to compensate for the erosion of patent protection by the time taken to get marketing approvals, and possibly TRIPS.

The Netherlands/ECJ

Cimetidine Injunction after patent expiry
Generics BV, which sells generic pharmaceuticals, wished to market Cimetidine, SKF's very successful anti-ulcer drug, as soon as the patent expired. Before the Netherlands patent expired, applications were filed with the Dutch regulatory authorities ("CBG") for marketing authorisations for Cimetidine accompanied by samples of Cimetidine. The applications were granted. SKF sued Generics BV for patent infringement on the basis that the submission of samples to the CBG infringed SKF's patents on Cimetidine.

The Dutch courts granted an injunction against Generics BV preventing them from making use of the registrations for 14 months after they were granted. The period of 14 months was considered to be the period it would normally take to obtain a marketing authorisation.

On a reference to it the ECJ stated that an injunction for 14 months after the expiry of the patents did constitute a measure having equivalent effect to a quantitative restriction on imports. However, both the injunction and its duration were justified by Article 36. Although the 14 month period is longer than that prescribed by the Directive, it does correspond to the actual average duration of the registration procedure and it is therefore just and not incompatible with Community law.

This decision will be widely welcomed by the research-based pharmaceutical industry, which has undoubtedly felt in recent years that both the European Commission and the ECJ has been reaching decisions largely on economic grounds, without proper regard to the rights of intellectual property right owners. The decision gives the European research-based pharmaceutical industry the full term of patent protection to prevent infringement by generic manufacturers. This contrasts with the position in the USA (by statute) and Germany (above), where the activities complained of in this case are legitimate.