BioCentury
ARTICLE | Company News

BioMarin, Sanofi, Duke University endocrine/metabolic news

March 16, 2015 7:00 AM UTC

The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) invalidated three patents covering methods for treating Pompe’s disease on the grounds of obviousness. BioMarin filed petitions requesting inter partes review of the patents. The patents -- U.S. Patent Nos. 7,655,226 and 7,351,410 from Sanofi’s Genzyme Corp. unit and U.S. Patent No. 7,056,712 B2 from Duke University -- covered a method of using a “therapeutically effective” amount of human acid alpha glucosidase (GAA) to treat Pompe’s disease. Genzyme’s ‘226 and ‘410 patents were set to expire in 2019 and 2020, respectively. Duke’s ‘712 patent was set to expire in 2023.

Genzyme markets Myozyme/ Lumizyme alglucosidase alpha for Pompe’s disease, which had sales of EUR542 million ($660.2 million) in 2014. Genzyme plans to appeal to the U.S. Federal Circuit. Genzyme is also developing Neo-GAA, a second-generation recombinant human GAA enzyme, which is in Phase I testing for the indication. ...