Biologics

114 articles available

After a decade-long hiatus, so-called Arrow declarations are now firmly back in fashion after the Court of Appeal’s judgment last year in Fujifilm Kyowa Kirin Biologics Co, Ltd v Abbvie Biotechnology…

Whilst being wary of placing too much emphasis on statistics (the phrase “lies, damn lies and statistics” comes to mind), the authors have seen figures which suggest that the last ten years have…

On October 8, 2017, the Chinese Communist Party and the State Council jointly issued a special opinion on the reform of drug and medical device approval system (“Innovation Opinion”). The Innovation…

The afternoon of the first day of C5’s Pharma & Biotech conference in Amsterdam (27 February 2018) concluded with a lively panel session on biosimilars. Chaired by Bristows partner Dom Adair, the…

The European Patent Office amends its Regulations in order to exclude from patentability plants and animals exclusively obtained by an essentially biological breeding process. The decision, during…

On 3 March 2017, the English Patents Court (Henry Carr J) issued a decision (here) in the joined claims filed by Fujifilm Kyowa Biologics (FKB) and Samsung Bioepis/Biogen (S/B) against AbbVie…

by Chloe Dickson On 30 November 2016 the Court of Appeal handed down judgment in the latest chapter of the Hospira v Genentech epic surrounding Genentech’s blockbuster drug trastuzumab (Herceptin®) …

Panel session 2 of the second day of the Congress was a discussion session about biosimilars. Moderator Dominic Adair (Partner, Bristows (UK)) led his panellists Fritz Reiter (Regulatory CMC Team…

Okay, this result, which was recently reached by TBA 3.3.04 in decision T 394/11 (in German language), may perhaps not come as a big surprise to you, since we all learnt in school that acetic acid is…