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Astrazeneca v. Teva, Court of Milan, 3 December 2020, docket number 7930/2020

On 3 December 2020, the Court of Milan rejected the claim of infringement of Astrazeneca patent EP 1272195 (“EP’195”) by the generic Fulvestrant of Teva and declared invalid the Italian portion of such patent for lack of inventive step. The decision also dealt with the issues of plausibility and of infringement in case of second medical use.

The decision issued by the Court of Milan on 3 December 2020 between Astrazeneca S.P.A Astrazeneca AB and Astrazeneca UK Limited (jointly “AZ” or “Plaintiffs”) and Teva Italia S.r.l. (“Teva”) rejected the infringement claim of AZ and declared the Italian portion of EP’195 invalid.

EP’195 is a second medical use patent. More specifically, it claims use of fulvestrant in “the treatment of a patient with breast cancer who previously has been treated with an aromatase inhibitor and tamoxifen and has failed with such previous treatment”.
AZ sought a declaration of infringement by Teva of the Italian portion of EP’195.

Teva sought – by way of counterclaim – a declaration of invalidity of the Italian portion of EP’195. Furthermore, the launch on the market by Teva of its drug led AZ to seek interim precautionary measures pending the proceedings on the merits.

The Court appointed panel of technical experts concluded that:

The entire summary can be read here.
The judgment (in Italian) can be read here.

Headnote and summary: Luca Giove and Giorgia Zecchin, GR Legal