Enantiomer of a known medicament held inventive and entitled to SPC

Against the backdrop of a number of recent European-wide negative decisions in which the validity of Supplementary Protection Certificates (SPC) was in contention, Daiichi's SPC for its Levofloxacin patent has been upheld. The UK court was not impressed with Generics (UK) Ltd's argument that the SPC was wrongly granted because it was not based on the marketing authorisation for the racemate, which contains levofloxacin. It was held that the racemate was a different product. The SPC was therefore rightly based on the later marketing authorisation for levofloxacin, which was the "first" for the relevant product.

Read Wragge & Co's expert analysis for a more in-depth look at the case.