Skip to content

IT – Teva v. Sicor / Bolar exemption

13 Sep 2021

With Decision No. 1785 of 8 June 2021, the Court of Appeal of Milan upheld Court of Milan Decision No. 8273 of 24 July 2018 finding Teva Pharmaceutical Industries Ltd. (“Teva”) and its Italian affiliate Sicor Società Italiana Corticosteroidi S.r.l (“Sicor”) liable for patent infringement.

The appeal court ruled that the Bolar exemption under Art. 68(1)(b) of the Italian Intellectual Property Code (“IPC”) does not apply to mere manufacturers of active pharmaceutical ingredients (“APIs”). And this regardless of whether the purchasers of the API use it for the purposes covered by the Bolar exemption.

Facts of the case
Boehringer Ingelheim Pharma GmbH & Co. KG. (“Boehringer”) is the holder of European patent no. 0418716 (“EP’716”), which was filed on 12 September 1990 and validated in Italy on 27 June 1994. EP’716 regards tiotropium bromide, an API used in Boehringer’s product Spiriva for the management of chronic obstructive pulmonary disease.

The entire summary can be read here.

The first instance decision can be read here.
The appeal decision can be read here.

Summary: Giulia Pasqualetto, BonelliErede