life sciences

The ECJ on market exclusivity for orphan drugs

(An Italian version is published on Diritto24 – Il Sole 24 Ore)

On 3 March 2016, the European Court of Justice (ECJ) issued its decision in C-138/15 P, Teva v. European Medicines Agency (EMA) dealing with orphan drugst (of which we already talked here on this blog). The Court dismissed […]

The European Court of Justice again on supplementary protection certificates

(The original Italian version is also published on Diritto 24 – Il Sole 24 Ore)

On 15 January, the European Court of Justice (“ECJ”) ruled in Case C- 631/13 concerning supplementary protection certificates (“SPCs”). As is known, this is a very relevant matter in the life sciences industry, which we […]

The Court of Milan in Sanofi v. Teva “repeats” the CJEU judgment in Actavis

(The original Italian version is published also on Diritto 24 – Il Sole 24 Ore)

By judgment No. 9855/14 published on 1 August, the Business Chamber “A” of the Court of Milan has decided the lawsuit filed by Sanofi against Teva for the infringement of supplementary protection certificate no. UB99P653 […]

EU General Court: EMA may not disclose clinical trials data

(by Francesca Maculan)

On 25 April, the President of the General Court of the European Union (“GC”) issued interim measures for suspension of operation of two decisions by the European Medicines Agency (“EMA”) granting third parties access to clinical trials data filed by pharmaceutical companies InterMune and AbbVie (jointly, the […]

European Commission fines Lundbeck for delaying market entry of generic medicines

Last 19 June, the European Commission (“EC”) imposed a fine of € 93,8 million on Danish pharmaceutical company Lundbeck, further than fines totalling € 52,2 million on several producers of generic medicines. The fines were imposed because Lundbeck had agreed with each of these companies to delay the market […]