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 Waiver for export purposes, dismissing claims brought by Amgen on multiple fronts (Dutch language judgment here and English machine translation here). It is the first judgment on the…
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 1 427 415 B1 (EP 415), which lapsed in 2022, and the corresponding supplementary protection certificates (SPCs) have been subject to litigation…
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 Development (PDP). The Ministry of Health published new guidelines (Ordinance #4,472/20241) as part of the government policy to foster the “National Strategy for the Development of the Economic-Industrial…
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 infringement with respect to Teva (which had admitted infringement with an earlier version of its product but sought a declaration of non-infringement…
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 the faith of all generics, as Teva found out in Dutch litigation over its generic version of Grünenthal’s Nebido:…
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 the European patent application 2 959 894. In its decision, the Court firmly stated that a preliminary injunction can only be issued based…
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…
