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11 September 2018Big PharmaGabriel Cuonzo and Luca Pellicciari

Boehringer v Teva: Italian court clarifies boundaries of Bolar privilege

With a ground-breaking decision issued on July 24, 2018, the Milan Court found Teva and its affiliate company Sicor liable for patent infringement in a case concerning Boehringer Ingelheim’s exclusive rights on the active pharmaceutical ingredient (API) tiotropium bromide, used in Boehringer Ingelheim’s product Spiriva for the management of chronic obstructive pulmonary disease.

Boehringer Ingelheim, represented by Trevisan & Cuonzo, filed for infringement of its supplementary protection certificate (SPC) covering tiotropium bromide after pre-trial search proceedings at the Milan premises of Teva’s Italian affiliate Sicor had revealed that Teva/Sicor had manufactured tiotropium bromide and offered it for sale, inter alia, via Teva’s website during the term of SPC protection. Teva/Sicor also supplied tiotropium bromide to customers within and outside the EU.

Teva/Sicor argued in court that their activities should be covered by section 68(1)(b) of the Italian Intellectual Property Code (implementing article 10[6] of Directive 2001/83/EC as amended by Directive 2004/27/EC, commonly referred to as the Bolar provision), which exempts studies, experiments and all “consequential practical requirements” aimed at obtaining a marketing authorisation for medicinal products.

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