Germany: Experimental Use Exception – Clinical Trials In Germany

In Les Nouvelles, the author had discussed the consequences of a landmark decision of the German Federal Supreme Court, keyword "Clinical Trials II", published in 1997, relating to the extent of the experimental use exception according to Art. 11.2 of the German Patent Act, reading in translation essentially as follows:

The German Federal Supreme Court (BGH) in the aforementioned decision had explicitly stated that clinical trials would be permitted even in cases where one of their purposes would be to obtain data for clinical approval, even if such trials would be conducted for the same indication as already known and protected, resp..

The author had expressed his opinion that as a consequence of "Clinical Trials II" even during the lifetime of a patent of another party clinical trials, even for the same substance and the same indication as protected, could be conducted, as long as the purpose of the clinical trials would not mean a "use" of the respective substance in any patent infringing manner during the lifetime of the patent, e. g. by distribution or manufacturing before the expiration of the patent, but only in order to get early market entrance as soon as the patent would have expired.

The aforementioned opinion of the author was heavily disputed and objected to, pointing to an appeal still pending at the time of publication of the aforementioned article in Les Nouvelles 1999 to the German Federal Constitutional Court, i.e. the highest court in Germany, whose decisions, different from those of any other court in Germany, have the character and scope of legislative acts, binding for everybody, not only "inter partes", i.e. which constitue laws.

In the meantime, the German Constitutional Court, by decision of May 10, 2001, published in GRUR 2001, pp. 43 ff., has confirmed Clinical Trials II, with the following results:

The decision of "Clinical Trials II" of the BGH is in full conformity with German constitution. According to German law, the experimental use exception applies whenever tests relate to the subject matter of the patented invention as such and have the purpose of obtaining additional informations. The BGH, as well as the Constitutional Court, do not distinguish between different uses of the information that is obtained by e. g. clinical trials. The only prerequisite is that the experiments that are done with the matter as protected are directed towards the generation of information. Whether this information is further used for the registration of medicaments or for filing of use patents (new indications) does not matter. The limitations that occur for the proprietor of the patent during its lifetime have to be accepted by its owner in view of the development of both the state of the art and public interest. Otherwise, according to the opinion of the Constitutional Court, a factual extension of a patent protection would occur which would not be justified.

Only a "commercial use under disguise" of the patented matter would be prohibited according to German case law as it stands now, which, however, under normal circumstances clearly would be distinguishable from e. g. clinical trials in order to obtain information leading to market approval.

Factually, because of the aforementioned case law in Germany, the country can be seen as being one of the most liberal in Europe, both with regard to experimental use exception in general as in relation to clinical trials, conducted either for the purpose of finding new indications or of getting market approval for patented indications that are still protected by the respective patents, with the aim of entering the market immediately after the expiration of the respective patent (or protection certificate, of course).