At the beginning of the year, the Russian Government granted the first compulsory license on a series of Big Pharma’s patents.  For the first time ever, “public security” clause has been evoked. According to the Decree 3718-r, Pharmasintez JSC, a Russian generic company, has been granted a 1-year compulsory license to use Gilead’s patents protecting…

The legislative procedure introducing an SPC manufacturing waiver in the European Union has been completed today on 11 June 2019 with the publication of the corresponding new Regulation (EU) 2019/933 of 20 May 2019 (PDF) in the Official Journal of the EU. The manufacturing waiver provisions will enter into force on the 20th day after…

44 U.S. states filed a lawsuit last Friday accusing Teva Pharmaceuticals USA of conspiring illegally with 19 other drug companies to inflate drug prices – sometimes by more than 1,000 percent – and stifle competition for generic drugs. As is set out in the complaint, ‘the Plaintiff States allege that Defendant Teva consistently and systematically,…

After the European Parliament adopted a controversial new regulation introducing an SPC manufacturing waiver for export and stockpiling in its last plenary session on 17 April 2019, as previously reported on this blog, the corresponding legislative act has now also been adopted by the Council of the European Union in its meeting today on 14…

The European Parliament has finally adopted the legislation introducing an SPC manufacturing waiver in its last plenary session before the upcoming European elections. The corresponding legislation was endorsed today on 17 April 2019, with 572 votes in favor, 36 votes against, and 22 abstentions. The vote was preceded by a discussion in plenum yesterday late…

The introduction of an SPC manufacturing waiver in the European Union is now all but a done deal. Following the European Commission’s initial proposal for a regulation amending Regulation (EC) 469/2009 on SPCs for medicinal products (COM(2018) 317 final) issued on 28 May 2018, the European Parliament’s Committee on Legal Affairs (JURI) adopted its final…

The introduction of an SPC “manufacturing waiver” in the European Union, aimed at boosting the competitiveness of EU-based generics and biosimilar industry, gains momentum as the current EU legislative period draws to a close. Under the EU’s legislative procedure, the European Commission’s initial proposal for a regulation amending Regulation (EC) 469/2009 on SPCs for medicinal…

Gilead Sciences vs Sandoz – Round One The history of the case started in 2018, where Gilead Sciences Inc., brought preliminary injunctions before the court against several companies. On 7 March 2018, the High Court of Eastern Denmark delivered a preliminary injunction against Accord Healthcare Limited, thereby reversing an earlier decision from the Danish Maritime…

The District Court of the Hague granted a provisional injunction against Sandoz’ generic darunavir product. As it was already offered in the G-standard, price erosion was an imminent danger for which a provisional injunction was warranted, and the SPC appeared to be valid having been held so in the parallell procedure before the UK court….

A consolidation and modernization of Europe’s intellectual property framework, featuring a “recalibration” of patent and SPC protection and possibly the creation of a unitary SPC title – those were the ambitious aims set out in the European Union’s single market strategy adopted in 2015. This was followed by a comprehensive evaluation of the legal aspects…