INFORMATION FROM THE CONTRACTING / EXTENSION STATES
DE Germany
Judgment of the Bundesgerichtshof (Federal Court of Justice), 10th Civil Senate, dated 17 April 1997
(X ZR 68/94)*
Headword: Klinische Versuche II (clinical tests II)
Sections 9 and 11.2 PatG (Patent Law)
Article 27(b) CPC
Keyword: "Right to conduct tests - a commercial objective in tests for the purposes of technical development does not constitute patent infringement - limits of right to test"
Headnote
1. A deliberate act intended to gain information shedding light on the effects and tolerability of a pharmaceutical's active substance constitutes an act performed for test purposes which is concerned with the subject-matter of the invention and therefore lawful.
2. Clinical tests of the effectiveness and tolerability of a pharmaceutical containing the protected active substance are also allowed if performed with the aim of gaining information for approval of a composition under pharmaceuticals legislation. The fact that a test has a commercial aim, and the intention to use for commercial purposes the knowledge thus gained, do not disqualify the test acts themselves as patent infringements.
3. If however the test itself has no bearing on the technical teaching, or involves trials on a scale not justified by its purpose or which are intended to disrupt or prevent the inventor's sales of his product, it is not an admissible act performed for test purposes within the meaning of Section 11.2.
DE 2/97
* Translation of the official headnote. A slightly abridged version of the decision is reported in Mitt. 1997, 254.