Generics

22 articles available

Introduction A key mechanism in patent litigation and specifically for generics is the concept of “launch at risk”. In short the concept means that a product is launched prior to the expiry of a…

 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…

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…

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…

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…

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…

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…

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…

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…