The EU Biotech Act is a legislative initiative aimed at simplifying biotech regulation, boosting innovation and investment, and strengthening Europe’s competitiveness and biotech ecosystem, which we…
BackgroundWe previously set out the background and genesis of the proposed regulatory provisions of the "Proposal for a Directive of the European Parliament and of the Council on the Union Code…
Preliminary injunctions (“PIs”) matter in life sciences patent cases. As often as not, the party which prevails at this stage of the litigation will have the upper hand in settlement negotiations. …
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…
