Biologics

25 May 2022, the Paris Court of Appeal overturned the refusal of the French National Institute of Industrial Property (INPI) to grant an SPC on avelumab. This is a reversal of the "nivolumab" case…

Submission of an abbreviated Biologics License Application (“aBLA”), under the Biosimilar Price Competition and Innovation Act of 2009 (“BPCIA”), for a biosimilar version of an already-approved…

If a patent only provides the skilled person with a general scientific explanation as to why the procedure disclosed therein is suitable for the purpose in question and does not disclose a new…

For manufacturers of biologics and biosimilars facing potential patent litigation in the U.S., the Biologics Price Competition and Innovation Act (BPCIA) imposes a complex statutory scheme that…

A consolidation and modernization of Europe’s intellectual property framework, featuring a “recalibration” of patent and SPC protection and possibly the creation of a unitary SPC title – those were…

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…