8
Feb 19
Using medicinal product trademarks in clinical trials prior to marketing authorization does not amount to genuine use, states advocate general szpunar
On January 9, 2019, Advocate General (AG) of the Court of Justice of the European Union (CJEU) Maciej Szpunar gave his opinion on case C-668/17 (“Opinion”), a trademark dispute that, while focusing on medicinal products, raised two other far-reaching issues concerning the scope and definition of the requirement of genuine use within the provisions of Article 58 of Regulation (EU) 2017/1001 of the European Parliament and of the Council of June 14, 2017 on the European Union trade mark (“EUTMR”).
1
Feb 19
The European Parliament legal affairs committee votes in favor of a comprehensive SPC manufacturing waiver
In May 2016, the European Parliament, in its Resolution on the Single Market Strategy, endorsed the need for changes to the EU supplementary protection certificate (“SPC”) and urged the Commission to introduce and implement an SPC manufacturing waiver before 2019, without undermining the market exclusivity granted under the SPC in the protected markets.
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.
2
Oct 17
Relevance of prosecution history in the assessment of the patent infringement by equivalents: a new trend in Italy
In a recent urgent decision, the Court of Milan held that the prosecution history must be taken into account, and is therefore relevant when assessing patent infringement by equivalence.
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.
