On December 23, the Brussels Enterprises Court issued a significant judgment confirming that Samsung Bioepis' notification complies with the legal requirements for relying on the SPC Manufacturing…
On 30 October 2024, the District Court of the Hague handed down two merits decisions on the widely litigated apixaban patent of Bristol-Myers Squibb (see here and here - Dutch language versions). EP…
Prepared by Rob Rodrigues, Brenno Telles and Dara Offrede
On Friday June 21, 2024, the government formally introduced regulations addressing the new framework for Partnerships for Productive…
A hefty judgment was recently handed down by Mellor J concerning a patent for a modified release formulation of mirabegron. The patent was held to be valid and not infringed by Sandoz, while…
The Status Quo injunction is not a variation on Wayne’s World classic “No Stairway, Denied” joke. While some may yearn for a ban on their generic tunes, Status Quo is still not denied. That is not…
In an appeal of a PI decision, the Danish Eastern High Court has ruled to uphold the dismissal of Novartis’ application for a preliminary injunction against Glenmark, Zentiva, and Viatris, based on…
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 (…
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…
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…
