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