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DE – AstraZeneca v. Hexal – fulvestrant and 2nd medical use

14 Feb 2019

AstraZeneca AB vs. Hexal AG, Court of Appeal Düsseldorf, docket no. I-2 U 29/18, with thanks to Cordula Schumacher, ARNOLD RUESS, for sending in the decision, translation and a headnote

*** Now including an English translation ***

The Düsseldorf Court of Appeal further specifies how to deal with 2nd medical use claims. The case dealt with the situation that the SmPC of the generic product did not include the patented indication (use of fulvestrant against breast cancer after failure of treatment with aromatase inhibitor and tamoxifen). Plaintiff held that a substantial part of the products are nevertheless used for the patented indication.

The Court found that without a manifest preparation (e.g. including the patented indication in the SmPC) there could only be a patent infringement if the generic product is actually used in an infringing way to a substantial amount.

This means that there need to be not only individual cases but to such extent that the generic company knows with certainty that there will be such use. In the present case, a scope of use of less than 7% of the overall market would not have been sufficient. In the end, the claim was dismissed because according to the claim construction of the Court, Plaintiff had not been able to show one single case of infringing use falling under the scope of the claims.

A copy of the judgment (in German) can be read here.
An English translation of the judgment can be read here.