3
Dec 17
CJEU and SPCs: a never-ending story
The work of the Court of Justice of the European Union (CJEU) on Regulation (EC) No. 469/2009 (Regulation), on supplementary protection certificates for medicinal products (SPCs), has been quite intense in the last few years, and it still is, given that in the pharmaceutical sector even one more day of exclusivity can be worth millions of euros, so fighting for it is certainly worth the investment of time and money.
1
Dec 17
EUCJ’s ruling on the classification of software as medical devices
According to a very recent ruling of the European Court of Justice (EUCJ), (C-329/16, Snitem v. Syndicat national de l’industrie des technologies médicales, published on 7 December 2017), software with at least one function that makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device, even if that software does not act directly in or on the human body.
4
Sep 17
The European Commission keeps targeting certain patent settlements between pharma companies as anticompetitive agreements: Cephalon and Teva formally accused of “pay-for-delay” in relation to a settlement the parties concluded in 2005
On July 17, 2017 Margrethe Vestagher, the head of antitrust at the European Commission (“Commission”), announced that its services sent a “statement of objections”[1] to the US-based originator company Cephalon Inc (Cephalon) and the Israeli generic company Teva Pharmaceutical Industry Ltd (Teva), accusing the two firms of infringing Article 101 of the TFEU (which prohibits anticompetitive agreements between independent undertakings) when they entered into a patent settlement agreement that, allegedly, had the objective of delaying the marketing in the EEA of a generic version of modafinil – a blockbuster drug for sleep disorders – despite the relevant patents had expired.
