On 15 to 17 December 2021 a three-day trial took place to determine preliminary issues in a second action brought by Neurim against Mylan in relation to patents protecting the product Circadin (“Neurim v Mylan 2021”).  Meade J’s judgment (Neurim Pharmaceutical (1991) Limited and Anor v Generics (UK) Limited t/a Viatris and Anor [2022] EWHC…

On 9 July 2021, the Court of Milan issued a preliminary injunction (PI) prohibiting a generic company from selling everolimus for use in combination with an aromatase inhibitor in the treatment of hormone receptor positive breast tumours.  The PI was issued on the basis of EP 3351246, which is one of the patents held by…

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 patent despite the risk that the patent proprietor in such case could initiate infringement proceedings which often includes requests for 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. 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…